Total 35 support analyst job vacancies in Quality Assurance / Control category in d04 harbourfronttelok blangah sentosa island

Responsibilities:

• Conduct sensory evaluation and ensure overall status of incoming and new raw materials (seasoning and liquid), including Glovia transactions.
• Manage the overall QC status of all final products and issue the appropriate type of labels for every final product.
• Perform Glovia transactions for final products to facilitate shipment.
• Issue various documents and reply technical enquiry raised internally or externally (e.g.. by customers).
• Conduct investigations on customers’ complaint samples or rejected items.
• Ensure lab stock is sufficient for lab use.
• Ensure preventive maintenance and external calibration of lab equipment is carried out duly.
• Ensure proper functioning and running of QC laboratories (Chemical, sensory, microbiology, retain sample room) in accordance with ISO9001, 5S, lean principle, ISO14000 and OSHAS 18001 standards and procedures.
• Assist and support in the implementation of continuous improvements in QA/QC functions.

Qualifications:

• Basic sensory skills
• Basic Chemistry
• Basic microbiology background

Key Responsibilities:

• Perform inspections on raw materials, intermediates and finished products by conduct sensory evaluation, carry out physical, analytical tests to ensure compliance with specifications and standards.
• Document non-conformance and conduct investigations on customers’ complaint samples or rejected items (Internal & External).
• Issue various documents (TDS, COA) and reply technical enquiry raised internally (e.g. inter-department, affiliates) or externally (e.g by customers).
• Ensure preventive maintenance and external calibration of lab equipment is carried out duly.
• Ensure proper functioning and running of QC laboratories (Chemical, sensory, microbiology, retain sample room) in accordance with ISO9001, 5S, lean principle, ISO14000 and OSHAS 18001 standards and procedures.
• Assist and support in the implementation of continuous improvements in QA/QC functions.
• Carry out ad-hoc duties as assigned, when and where necessary.

Qualifications:

• Minimum Diploma or Degree in Chemistry, Food Science and Technology, Analytical Chemistry or equivalent in years of similar experience.
• Overall work experience of 2 to 3 years in a similar position.
• Basic knowledge & interpretation of gas chromatography, knowledge of densimeter and refractive index equipment preferred.
• Basic knowledge of chemistry.
• Basic Sensory evaluation capability / potential capability preferred.
• SAP knowledge will be an advantage.

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Did you know that we are the 1st biologics contract manufacturer in Singapore? We offer you exposure to upcoming biotech and established pharmaceutical companies and to the manufacturing technology needed to produce mammalian treatments and cell therapies of tomorrow. Our global manufacturing network is recognized for its reliable, high-quality services, regulatory track record, global footprint, innovative technology platforms and extensive experience – we, in Singapore are proud to be part of this global network.

The QC Analyst will encompass a good understanding and execution of intermediate and advanced microbiology techniques (bioburden, LAL, plating and counting techniques, microbial identification, EM tests i.e. air sampling, surface viable sampling, total particulate sampling etc.). Collecting environmental monitoring samples from different areas of the facilities, generation of required trending and reporting information. Role will also assist in process and/ or environmental microbiology related investigations as required.

Key responsibilities:

• To prioritize and perform the various testing/analysis in timely manner, in order to support the business requirements.
• Analysis of bulk product, in-process, raw material or environmental samples according to Standard Operating Procedures and Test Methods.
• Documentation of results in accordance with current Good Manufacturing Practices (cGMP).
• Problem solving of analytical methods as well as troubleshooting of equipment.
• Involvement in method transfers and validation.
• Involved in equipment qualification and technical selection of QC equipment and/or standards and reagents.
• Assay trend analysis, document revision and update.
• General lab support including housekeeping, equipment maintenance, inventory of supplies, lab supplies ordering, management of glass wares, autoclaving etc.
• Any other duties as assigned by your Supervisor/Manager

Key requirements:

• Degree/Diploma in a relevant Chemistry, Science field or Equivalent
• Relevant experience and accomplishment to dictate final position for which the candidate may qualify
• Well versed in cGMP regulations
• Knowledge of area specific responsibilities
• Good problem solving and analytical skills.
• Good communication skills
• A key team player.
• Working hours: Shift pattern

Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieve ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Did you know that we are the 1st biologics contract manufacturer in Singapore? We offer you exposure to upcoming biotech and established pharmaceutical companies and to the manufacturing technology needed to produce mammalian treatments and cell therapies of tomorrow. Our global manufacturing network is recognized for its reliable, high-quality services, regulatory track record, global footprint, innovative technology platforms and extensive experience – we, in Singapore are proud to be part of this global network.

This role is responsible for conducting test and scheduling/coordinating of testing with other departments to ensure timely delivery of results. This role is also required to perform peer review of laboratory data, support OOS and Deviation investigation.

Responsibilities

• Analysis of final product, in-process, raw material or environmental samples according to Standard Operating Procedures and Test Methods.
• Documentation and review of results in accordance with current Good Manufacturing Practices (cGMP).
• Problem solving of analytical methods as well as troubleshooting of equipment.
• Involvement in method transfers and validation.
• Involved in equipment qualification and technical selection of QC equipment and/or standards and reagents.
• Assay trend analysis, document revision and update.
• General lab support includes housekeeping, equipment maintenance, inventory of supplies, lab supplies ordering, management of glass wares, autoclaving etc.
• Assay trend analysis, document version and update.
• Independently lead and conduct OOS, deviation investigations. Draft investigations reports.
• Support in team leadership and driving results to meet department KPIs.
• SME in 1 or more areas as aligned with the training plan.
• Able to make decisions independently on the area of expertise.
• Coach and train junior team members.
• Practice and support audit activities
• Any other duties as assigned by your Supervisor/Manager

Experience

• Degree/Diploma in a relevant Science field or Equivalent.
• Understanding and execution of spectroscopy and other assigned methods which may include chromatography methods (HPLC), ELISA, PCR, CE, SDS-PAGE, IEF, icIEF, TOC , Protein Concentration (A280 or SoloVPE), osmolality, potency methods, appearance and other physiochemical methods.
• Work experience preferably Lab experience in a biotech or medically related field
• Relevant experience and accomplishment to dictate final position for which the candidate may qualify
• Good problem solving and analytical skills

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

No deviation is a provider of patient-centric solutions for the pharmaceutical industry, and we are currently seeking individuals who are passionate about joining our team. Our areas of expertise include engineering consultancy, Commissioning Qualification Validation (CQV), as well as Quality, Compliance, and Regulatory services.

We strongly uphold our core values of Empathy, Integrity, and Transparency, and we strive to create a collaborative, innovative, and inclusive work environment that fosters personal growth and development.

By joining our team, you will have the opportunity to make a meaningful impact in the pharmaceutical industry while advancing your career.

This role ensures that all raw materials meet established quality standards and regulatory requirements to support manufacturing processes. The ideal candidate will have strong attention to detail, experience in analytical testing, and knowledge of pharmaceutical QC practices.

Key Responsibilities:

· Conduct Testing and Analysis: Perform qualitative and quantitative testing on raw materials following standard operating procedures (SOPs), Good Laboratory Practices (GLP), and Good Manufacturing Practices (GMP).

· Sample Preparation: Prepare samples of raw materials for analysis using appropriate techniques and equipment, such as HPLC, GC, FTIR, UV-Vis spectroscopy, and wet chemistry methods.

· Documentation and Reporting: Accurately document test results and observations, maintain detailed laboratory records, and prepare reports in compliance with regulatory standards.

· Compliance and Safety: Adhere to all quality and safety standards within the laboratory, ensuring all work is conducted according to regulatory guidelines (FDA, EMA) and company policies.

· Instrument Calibration and Maintenance: Ensure that laboratory equipment is properly calibrated and maintained; troubleshoot issues and coordinate with the maintenance team as needed.

· Inventory Management: Monitor raw material inventory levels, including reagents and supplies, and coordinate with the purchasing team to replenish stocks.

· Continuous Improvement: Participate in continuous improvement initiatives to enhance lab efficiency, accuracy, and safety, and identify potential areas for process optimization.

· Collaboration and Communication: Work closely with cross-functional teams, including production, QA, and R&D, to ensure timely support and resolution of QC issues.

Qualifications:

· Education: Diploma or Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field.

· Experience: 1–3 years of experience in a QC laboratory within the pharmaceutical or biotech industry, with a focus on raw materials (experience with GMP and GLP preferred).

· Technical Skills: Proficiency in analytical testing techniques, especially HPLC, GC, FTIR, and wet chemistry methods. Familiarity with Laboratory Information Management Systems (LIMS) is a plus.

· Attention to Detail: Strong attention to detail and accuracy in testing, documentation, and reporting.

· Regulatory Knowledge: Understanding of industry regulations and standards, including FDA, ICH, and USP guidelines for raw materials.

Work Environment:

· Ability to work in a laboratory setting, which may involve exposure to chemicals and use of protective equipment.

· May require occasional lifting of equipment or samples (up to 25 lbs).

• Ensure the proper upkeep of equipment and systems in the QC IPC/DS laboratory to maintain full compliance with cGMP standards as part of the shift team.
• Conduct product testing and analysis in accordance with cGMP guidelines to meet specified deadlines.
• Offer technical assistance in running and validating necessary testing methods on laboratory equipment and in the development of method transfer/validation protocols and reports.
• Conduct routine analytical testing for in-process, release, stability test, and validation samples, including but not limited to HPLC, UV, TOC, pH, and more.
• Effectively manage work priorities to ensure timely document review and testing.
• Create and review QC documents, encompassing assays of varying complexity, to guarantee their completeness, accuracy, consistency, and clarity, ensuring that materials or final products align with specifications and cGMP standards.
• Prepare for and participate in inspections by health authorities and internal audits within the respective area.

Find what drives you on a team with a more than 75-year history of discovery, determination, and innovation. As a global leader in high-tech filtration, separation, and purification, Pall Corporation thrives on helping our customers solve their toughest challenges. Our products serve diverse, global customer needs across a wide range of applications to advance health, safety and environmentally responsible technologies. For the exponentially curious, Pall is a place you can thrive and amplify your impact on the world.

Pall is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.

Learn about the Danaher Business System which makes everything possible.

The QC Analyst is responsible to execute testing, sampling and inspection procedures on raw materials, equipment, in-process materials, and/or finished products to ensure that product specifications and company and regulatory requirements are met.

This position is part of the Quality Control Department reporting to the QC Manager and will be located in Benoi, Singapore.

In this role, you will have the opportunity to:

• Carry out day-to-day testing including preparation of standards and samples and escalating the failed and risky products.
• Support plant initiatives on PSP, 5S, ESH, Engagement and Kaizen.
• Support to drive lab vision, ensure execution of lab vision to meet company business and production requirement.

The essential requirements of the job include:

• Minimum ITE/ Higher Nitec/ Diploma in related Science.
• Ability to read/write in English.
• Computer skills – Excel, Word, Typing and Data entry skills.
• Working in 12 hours shift in a cleanroom environment with the gowning procedure.

It would be a plus if you also possess previous experience in:

• Exposure experience to ICP-MS / GC-MS / Liquid Particle Counter/ TOC.
• Good understanding of GMP, GDP, GLP and Quality parameters in QC operations.

Pall Corporation, a Danaher company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at danaherbenefitsinfo.com.

Administered by the Workforce Advancement Federation (WAF), the Career Conversion Programme (CCP) for Biomedical Manufacturing Executives is a premier talent development initiative designed to cultivate the next generation of skilled professionals for Singapore’s Biomedical manufacturing industry. This comprehensive 15-month programme features structured on-the-job training (OJT) provided at Novartis Singapore Pharmaceutical Manufacturing Pte Ltd (NSPM), facilitating the practical application of acquired knowledge and ensuring participants develop the essential competencies required for their roles.

Eligilibity for CCP:

• Singapore Citizen or Permanent Resident;

• Minimum 21 years old;

• Mid-Career Individual: Graduated, or completed National Service, whichever is later, for at least 2 years* prior at the point of application; or

• Fresh Graduate: Graduated, or completed National Service, whichever is later;

• Not in a similar job function prior to joining Career Conversion Programme (CCP);

• Have not attended the same programme – Career Conversion Programme (CCP) for Biomedical Manufacturing Executives / Professionals (Train-and-Place with Commitment to hire) – previously;

• Have not been funded under the same programme – Career Conversion Programme (CCP) for Biomedical Manufacturing Executives / Professionals (Train-and-Place with Commitment to hire) – previously.

• Should not be shareholders, immediate ex-employees of Novartis, or be related to shareholders of Novartis.

Successful candidates must be able to commence the program by March 2025.

Job Purpose

Responsible for providing quality oversight to ensure smooth manufacturing operation and new product launches/transfer in a compliant and timely manner. Support drug substance batch review and release in full gmp compliance to regulatory standards and ensures quality strategy/continuous improvement are executed in alignment to site objective/s.

Key Responsibilities

Operational

a. Provide Quality oversight to site operations/objectives

· Oversight of all production and testing activities, ensures compliance with cGxP, incl. data integrity and eCompliance.

· Participate/Support meetings (as required) and team tiered process to monitor/detect/act on anomalies to key site quality KPIs and continuous improvement.

b. Review/ Release of Raw materials and manufactured materials

· Perform and be responsible in ensuring Batch record review and/or release (raw materials and manufactured materials – for authorized person only) is in full cGMP compliance to regulatory and Novartis Quality Standards

· Support the release team in batch release in ensuring batch release (manufactured materials – for authorized person only) is in full cGMP compliance to regulatory and Novartis Quality Standards.

c. Support exception investigations and change control activities

· Lead/support in ensuring a smooth manufacturing operations in production/QC/Logistics, in handling deviations/capa, change control, complaints, customer management, escalation, recall etc are in full cGMP compliance to regulatory and Novartis Quality Standards

d. Support OpEx improvement projects

· Support for end-to-end lifecycle management, timely review & escalation, stakeholder management to achieve agreed outcomes for projects assigned and areas under responsibility

e. New Product Introduction

· Support in ensuring success to new product launch/transfer and equipment/product lifecycle management are in full cGMP compliance to regulatory and Novartis Quality Standards e.g., Product Transfer, Equipment Qualification, Computerized System Validation, Shipping Validation, Cleaning Validation, , Process Validation, Ongoing Process Verification & etc

f. Customer Management

· Lead/support network/project governance meeting and team tiered process to monitor/detect/act on anomalies to project milestones, KPIs and continuous improvement.

· Support in preparing customers request documentation or requests

g. Documents review

· Provide support (Review/Approval) of GMP Record/Document in ensuring compliance to regulatory and Novartis Quality Standards

h. Inspections

· Provide support in ensuring inspection readiness. Support customer, internal Novartis and Health Authority audits.

i. Any other task/duties assigned by Line Manager

Requirements

· University degree with a scientific / technological background (e.g. Chemistry, Pharmacy, Biology, Biochemistry, or equivalent)

· Several years of experience in pharmaceutical quality control, quality assurance or production or relevant quality experience. Fresh graduates are welcome to apply.

· Operations Management and Execution; Functional Breadth; Collaborating across boundaries; Applied Practice

· New entrants to biopharmaceutical industry and should not be holding a bond obligation with any organisation

Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Did you know that we are the 1st biologics contract manufacturer in Singapore? We offer you exposure to upcoming biotech and established pharmaceutical companies and to the manufacturing technology needed to produce mammalian treatments and cell therapies of tomorrow. Our global manufacturing network is recognized for its reliable, high-quality services, regulatory track record, global footprint, innovative technology platforms and extensive experience – we, in Singapore are proud to be part of this global network.

As a Senior QC Analyst, you will leverage your technical expertise in a variety of testing techniques and collaborate with cross-functional teams to ensure timely project delivery.

Requirement:

• Provide technical leadership in biochemical testing, including cell counts, flow cytometry, ELISA, PCR analysis, and compendial testing (pH, Conductivity, Appearance) as per USP, JP, and EP standards.
• Troubleshoot equipment and method-related issues by analyzing data and trends to resolve problems.
• Collaborate with tech transfer teams to introduce new processes or modify existing ones, acting as the lab's designated point of contact.
• Lead complex projects, coordinating various project teams to ensure successful completion and effective communication across all stakeholders.
• Prepare and manage project documentation, including Method Transfer, Qualification, Validation reports, and product stability programs.
• Oversee preventative maintenance and requalification of stability-related equipment.
• Contribute to Annual Product Reviews and regulatory documents and provide guidance to junior staff.
• Support continuous improvement initiatives and participate in audit activities when needed.
• Proactively communicate risks to managers and the Head of QC.

Requirements:

• Degree in a relevant scientific field or equivalent.
• 5-10 years of QC experience, preferably in biotech, healthcare, or life sciences.
• Expertise in bioassays (ELISA, PCR, FACS) and ability to maintain quality standards while achieving results.
• Strong analytical and decision-making skills, with a desire to continuously learn and grow.

Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Did you know that we are the 1st biologics contract manufacturer in Singapore? We offer you exposure to upcoming biotech and established pharmaceutical companies and to the manufacturing technology needed to produce mammalian treatments and cell therapies of tomorrow. Our global manufacturing network is recognized for its reliable, high-quality services, regulatory track record, global footprint, innovative technology platforms and extensive experience – we, in Singapore are proud to be part of this global network.

Responsibilities:

• Perform various testing/analysis (bioburden, LAL, plating and counting techniques, microbial identification, EM tests i.e. air sampling, surface viable sampling, total particulate sampling etc.) in timely manner.
• Collecting environmental monitoring samples from different areas of the facilities, generation of required trending and reporting information. Assist in process and/ or environmental microbiology related investigations as required.
• Analysis of bulk product according to Standard Operating Procedures and Test Methods.
• Documentation of results in accordance with current Good Manufacturing Practices (cGMP).
• Problem solving of analytical methods as well as troubleshooting of equipment.
• Involvement in method transfers and validation.
• Involved in equipment qualification and technical selection of QC equipment and/or standards and reagents.
• Generation of required trending and reporting information, document revision and update.
• Support / Perform OOS, deviation investigations. Draft investigations reports.
• General lab support including housekeeping, equipment maintenance, inventory of supplies, lab supplies ordering, management of glass wares, autoclaving etc.
• Any other duties as assigned by your Supervisor/Manager

Experience

• Degree/Diploma in a relevant Science field or Equivalent
• 0-5 years’ experience in Quality Control
• Strong knowledge of microbiological laboratory operations in a manufacturing environment
• Demonstrates an ability and desire to learn from experience
• Good problem solving and analytical skills
• Good communication skills
• Experience with USP 71 Sterility testing is preferred

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Quality Lab Support Coordinator

6 months contract

About the Company:
Our client is a US healthcare and a leading global biopharmaceutical company. They have a revenue of US $40.1 billion, with more than 69,000 employees across 140 countries with a heritage of more than 125 years. Our client is committed to provide patients and customers with a reliable supply of high-quality, safe, and effective medicines and vaccines. Their global supply strategy relies on manufacturing capabilities and expertise to achieve this mission

Responsibilities:

In this role, you will be responsible for all or subset of the key responsibilities below:

• Receive, archive, retrieve and dispose retention sample, following standard work, approved procedures and regulatory requirements in timely manner.
• Maintain proper 5S and ensure inspection readiness of retention sample rooms.
• Perform assigned tasks within stipulated timeline and escalate discrepancies to Reporting Manager.
• Support laboratory supplies stock check, receiving, stock arrangement and disposal as necessary.
• Any other duties as assigned by reporting manager.

Requirements:

• GCE O Level qualification and above
• Proficient with computer software such as Microsoft Word & Excel
• The role will require the person to be able to move heavy boxes up to 15 KG during process like transfer of samples/stocks checking.
• Customer focus with strong business acumen and continuous improvement mindset.
• Critical thinking mindset with a collaborative and problem-solving attitude.
• Good communication and interpersonal skills.
• Ability to work effectively in a team-based environment.

Reg No: R22104540

EA License no: 94C3609

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Did you know that we are the 1st biologics contract manufacturer in Singapore? We offer you exposure to upcoming biotech and established pharmaceutical companies and to the manufacturing technology needed to produce mammalian treatments and cell therapies of tomorrow. Our global manufacturing network is recognized for its reliable, high-quality services, regulatory track record, global footprint, innovative technology platforms and extensive experience – we, in Singapore are proud to be part of this global network.

The QC Analyst will be responsible for Biochemistry Area in the QC Lab to support Lot Release activities

Responsibilities

• Prioritize and perform the various testing/analysis in timely manner, in order to support the business requirements.
• Analysis of final product, in-process, stability samples according to Standard Operating Procedures and Test Methods.
• Documentation and review of results in accordance with current Good Manufacturing Practices (cGMP).
• Understanding and execution of methods which may include ELISA, PCR, CE, SDS-PAGE, IEF, icIEF, potency methods, and other physiochemical methods.
• General lab support including housekeeping, equipment maintenance, inventory of supplies, lab supplies ordering, management of glass wares, autoclaving etc.
• Prepare, maintain standards and reagents as required by GMP documents.
• Responsible to follow data integrity requirements.
• Actively contributes to operational efficiency/continuous improvement initiatives.
• Problem solving of analytical methods as well as troubleshooting of equipment.
• Involved in equipment qualification, maintenance and troubleshooting.
• Support / Perform OOS, deviation investigations. Draft investigations reports.
• Be a trainer for test method.
• Involvement in method transfers and validation.
• Author Change Controls, Test Methods, SOPs.
• Lead Out-Of- Specifications (OOS) and deviation investigations.

Education / Experience

• Diploma / Degree or higher from recognized institution with at least 3 years’ experience in Quality unit in the Biopharmaceutical industry
• Relevant work experience preferably Lab experience in a biotech or medically related field
• Familiar with Regulatory requirements and local Codes & Standards (e.g., FDA, EMEA, and ICH Guidelines)
• Good knowledge and experience of the practical and theoretical requirement of quality management system in GMP facility
• Is willing to take on new challenges
• Good interpersonal skills
• Effective Communicator (oral and written)
• Plans, prioritizes and organizes work to deliver on time
• Exhibit good quality decision making traits
• Meticulous and Systematic and Analytical Mind
• Team player who can operate independently, with strong focus on safety, quality and timelines

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Find what drives you on a team with a more than 75-year history of discovery, determination, and innovation. As a global leader in high-tech filtration, separation, and purification, Pall Corporation thrives on helping our customers solve their toughest challenges. Our products serve diverse, global customer needs across a wide range of applications to advance health, safety and environmentally responsible technologies. For the exponentially curious, Pall is a place you can thrive and amplify your impact on the world.

Pall is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.

Learn about the Danaher Business System which makes everything possible.

The QC Analyst is responsible to execute testing, sampling and inspection procedures on raw materials, equipment, in-process materials, and/or finished products to ensure that product specifications and company and regulatory requirements are met.

This position is part of the Quality Control Department reporting to the QC Manager and will be located in Benoi, Singapore.

In this role, you will have the opportunity to:

• Carry out day-to-day testing including preparation of standards and samples and escalating the failed and risky products.
• Support plant initiatives on PSP, 5S, ESH, Engagement and Kaizen.
• Support to drive lab vision, ensure execution of lab vision to meet company business and production requirement.

The essential requirements of the job include:

• Minimum ITE/ Higher Nitec/ Diploma in related Science.
• Ability to read/write in English.
• Computer skills – Excel, Word, Typing and Data entry skills.
• Working in 12 hours shift in a cleanroom environment with the gowning procedure.

It would be a plus if you also possess previous experience in:

• Exposure experience to ICP-MS / GC-MS / Liquid Particle Counter/ TOC.
• Good understanding of GMP, GDP, GLP and Quality parameters in QC operations.

Pall Corporation, a Danaher company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at danaherbenefitsinfo.com.

Job Description

This role will be responsible to establish and ensure testing of drug substance release and stability testing including testing of intermediates in process control samples and lab operations are accordance with written testing SOP’s and local/international regulations.

About the Role:

Execution of assigned tasks in the quality control laboratory in accordance with cGxP regulations. Performance of laboratory specific activities such as analyses, maintenance, calibration and qualification of analytical equipment.

Key Responsibilities:

• Sample storage and management.
• Analytical testing and documentation of API / drug substance / drug product / finished product / Complaints / stability / packaging material samples.
• Ensure all activities in compliance with cGxP, incl. data integrity
• Stability (when not centralized).
• Testing/Sample storage and management.
• Analytical documentation of stability samples to cGxP standards
• Comply with all HSE guidelines.
• Detect and report potential accident, risks and propose solutions.
• Responsible for participating in initial training and retraining.
• Able to support rotating shift hours (Day/night).

Role Requirements:

Essential Requirements:

• Preferred: Previous experience working in a laboratory environment in the pharmaceutical industry (quality assurance, production), aseptic technique.
• Administrative activities and GMP and HSE-compliant, efficient production and documentation of standardized tasks in the infrastructure.
• Breakthrough Analysis; Being Resilient; Operational Excellence; Continuous Learning; Digital & Tech Savvy.
• Laboratory equipment; Quality Control (QC) Testing; Quality Control Sampling; knowledge of TQM and related industry GxP standards and processes; Laboratory Excellence; Quality decision making.
• Ensure proper maintenance of QC IPC/DS lab equipment and systems to ensure full cGMP-compliance as part of shift team.
• Perform product testing and analysis under cGMP to meet required timelines.
• Provide technical support to run and validate necessary test methods on lab equipment and in developing method transfer/validation protocols and reports.
• Perform routine testing for in process, release and stability test samples and validation samples.
• Support and validate necessary test methods on lab equipment under cGMP.
• Prioritizes workload to ensure documents are reviewed and testing is performed in a timely manner.
• Support and coordinate laboratory investigations and facilitates root cause finding.
• Prepare and check QC documents, including assays of least to average complexity, to ensure completeness, accuracy, consistency, and clarity and that materials or final products have been manufactured, tested, or inspected according to specification and cGMPs.
• Support the execution of improvements to optimize test procedures or efficiency whenever possible.
• Prepare and participate in health authorities inspections and internal audits in respective area.

Desirable Requirements:

• University degree with a scientific / technological background (e.g. Chemistry, Pharmacy, Biology, Biochemistry, or equivalent).

Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network.

Skills Desired

Continuous Learning, Decision Making, Gxp, Industry Standards, Laboratory Excellence, Laboratory Instrumentation, Managing Ambiguity, Quality Control (Qc) Testing, Quality Control Sampling, Self-Awareness, Technical Knowledge, Total Quality Management (TQM)

Job Description Summary

This role utilizes chemistry laboratory skills to test and measure product or raw materials while ensuring that analysis is performed according to established Standard Operating Procedures (SOPs), Analytical Methods & current Compendia.

Job Description

Key Responsibilities:

• Sample storage and management -Analytical testing/documentation of incoming raw material samples to GxP standards Testing/Sample storage and management.
• Analytical documentation of raw material samples to GxP standards -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable).

Essential Requirements:

• QC testing of all incoming raw materials as per cGMP standards.
  Familiar with major pharmacopeia standards such as USP, EP, JP/JPE, ChP etc.
  Deadline adherence rate: testing completed on time, all missed deadlines reported in good time, the shortest possible lead time. Ensure constant readiness for inspection, no critical complaints/observations from superiors and inspectors.
• Consistently follow the GMP and GDP guidelines, as well as the SOPs, no critical irregularities.
• Finding and implementing optimization options to reduce costs.
• Completed training plan.
  Sound technical & scientific knowledge of pharmaceutical/ chemical.
• Working experience in Laboratory environment in the Pharmaceutical analytics/QC/ equivalent industry.

Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network.

Skills Desired

Continued Learning, Decision Making, Gxp, Industry Standards, Laboratory Excellence, Laboratory Instrumentation, Managing Ambiguity, Quality Control (Qc) Testing, Quality Control Sampling, Self-Awareness, Technical Knowledge, Total Quality Management (TQM)

Job Description Summary

This role utilizes chemistry laboratory skills to test and measure product or raw materials while ensuring that analysis is performed according to established Standard Operating Procedures (SOPs), Analytical Methods & current Compendia.

Job Description

Key Responsibilities:

• Sample storage and management -Analytical testing/documentation of incoming raw material samples to GxP standards Testing/Sample storage and management.
• Analytical documentation of raw material samples to GxP standards -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable).

Essential Requirements:

• QC testing of all incoming raw materials as per cGMP standards.
  Familiar with major pharmacopeia standards such as USP, EP, JP/JPE, ChP etc.
  Deadline adherence rate: testing completed on time, all missed deadlines reported in good time, the shortest possible lead time. Ensure constant readiness for inspection, no critical complaints/observations from superiors and inspectors.
• Consistently follow the GMP and GDP guidelines, as well as the SOPs, no critical irregularities.
• Finding and implementing optimization options to reduce costs.
• Completed training plan.
  Sound technical & scientific knowledge of pharmaceutical/ chemical.
• Working experience in Laboratory environment in the Pharmaceutical analytics/QC/ equivalent industry.

Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network.

Skills Desired

Continued Learning, Decision Making, Gxp, Industry Standards, Laboratory Excellence, Laboratory Instrumentation, Managing Ambiguity, Quality Control (Qc) Testing, Quality Control Sampling, Self-Awareness, Technical Knowledge, Total Quality Management (TQM)

Quality Support, Specialist

(12 month contract)

About the Company:

Our client is a US healthcare and a leading global biopharmaceutical company. They have a revenue of US $40.1 billion, with more than 69,000 employees across 140 countries with a heritage of more than 125 years. Our client is committed to provide patients and customers with a reliable supply of high-quality, safe, and effective medicines and vaccines. Their global supply strategy relies on manufacturing capabilities and expertise to achieve this mission

Primary Responsibilities:

The role will ensure and maintain high standards of quality and compliance within client’s organization.

In this role, you will be responsible for all or subset of the key responsibilities below:

• Perform laboratory system lifecycle management, including system qualification/retirement, commissioning/decommissioning, calibration and maintenance, system administration, and periodic reviews, in accordance with approved procedures and standard lead time.
• Raise Computerize Maintenance Management System (CMMS) request form to create/update/delete SAP master data related to laboratory system.
• Raise purchase request and perform orders confirmation and accrual for laboratory system lifecycle management, inventories, maintenance and repairs orders.
• Liaise with vendor to ensure contractor management documentation and assigned vendor tasks are completed within assigned lead time.
• Perform and review of Quality documents such as eshopfloor logs, eVal and etc.
• Assist in conducting laboratory investigations and ensure effective implementation of related actions within the agreed timeframe.
• Provide inputs for the development and revision of Standard Operating Procedures, Work Instructions and other GMP documents.
• Maintain proper laboratory/storage area housekeeping/5S and ensure inspection readiness.
• Execute section and Quality improvement initiatives and other special projects.
• Any other duties as assigned by reporting manager
• Provide skills training to other team members, ensuring they have the necessary knowledge and competencies to perform their duties effectively.
• Conduct troubleshooting of laboratory system lifecycle, identifying and resolving any issues that may impact the business/work efficiency.
• Assume role of Subject-Matter-Expert of laboratory system lifecycle, collaborates closely with other site and above-site functions. This includes actively participating in discussions, sharing expertise, and providing input to ensure alignment and consistency across the organization.
• Support Reporting Manager in planning of routine operations tasks to ensure completion within stipulated timeline.
• Support and respond to audit requirements and findings.
• Perform assessments of compendial updates and implement changes to Standard Operating Procedures, Work Instructions and other GMP documents.

Requirements:

• Diploma or Bachelor’s degree in Science/ Life Science, Pharmaceutical Science or Engineering or any other relevant field
• At least 3 years of relevant working experience in GMP environment with quality control laboratory experience within the pharmaceutical/chemical manufacturing.
• Competency in analytical chemistry tools such as HPLC, root cause analysis methods and tools.

Reg No: R22104540

EA License no: 94C3609

Quality Support, Associate Specialist

(12 month contract)

About the Company:

Our client is a US healthcare and a leading global biopharmaceutical company. They have a revenue of US $40.1 billion, with more than 69,000 employees across 140 countries with a heritage of more than 125 years. Our client is committed to provide patients and customers with a reliable supply of high-quality, safe, and effective medicines and vaccines. Their global supply strategy relies on manufacturing capabilities and expertise to achieve this mission

Primary Responsibilities:

The role will ensure and maintain high standards of quality and compliance within client’s organization.

In this role, you will be responsible for all or subset of the key responsibilities below:

• Perform laboratory system lifecycle management, including system qualification/retirement, commissioning/decommissioning, calibration and maintenance, system administration, and periodic reviews, in accordance with approved procedures and standard lead time.
• Raise Computerize Maintenance Management System (CMMS) request form to create/update/delete SAP master data related to laboratory system.
• Raise purchase request and perform orders confirmation and accrual for laboratory system lifecycle management, inventories, maintenance and repairs orders.
• Liaise with vendor to ensure contractor management documentation and assigned vendor tasks are completed within assigned lead time.
• Perform and review of Quality documents such as eshopfloor logs, eVal and etc.
• Assist in conducting laboratory investigations and ensure effective implementation of related actions within the agreed timeframe.
• Provide inputs for the development and revision of Standard Operating Procedures, Work Instructions and other GMP documents.
• Maintain proper laboratory/storage area housekeeping/5S and ensure inspection readiness.
• Execute section and Quality improvement initiatives and other special projects.
• Any other duties as assigned by reporting manager
• Provide skills training to other team members, ensuring they have the necessary knowledge and competencies to perform their duties effectively.
• Conduct troubleshooting of laboratory system lifecycle, identifying and resolving any issues that may impact the business/work efficiency.
• Assume role of Subject-Matter-Expert of laboratory system lifecycle, collaborates closely with other site and above-site functions. This includes actively participating in discussions, sharing expertise, and providing input to ensure alignment and consistency across the organization.
• Support Reporting Manager in planning of routine operations tasks to ensure completion within stipulated timeline.
• Support and respond to audit requirements and findings.
• Perform assessments of compendial updates and implement changes to Standard Operating Procedures, Work Instructions and other GMP documents.

Requirements:

• Diploma or Bachelor’s degree in Science/ Life Science, Pharmaceutical Science or Engineering or any other relevant field
• At least 1 year of relevant working experience in GMP environment with quality control laboratory experience within the pharmaceutical/chemical manufacturing.
• Competency in analytical chemistry tools such as HPLC, root cause analysis methods and tools.

Reg No: R22104540

EA License no: 94C3609

Job Description

• Perform inspections on raw materials, intermediates and finished products by conduct sensory evaluation, carry out physical, analytical tests to ensure compliance with specifications and standards.
• Document non-conformance and conduct investigations on customers’ complaint samples or rejected items (Internal & External).
• Issue various documents (TDS, COA) and reply technical enquiry raised internally (e.g. inter-department, affiliates) or externally (e.g by customers).
• Ensure preventive maintenance and external calibration of lab equipment is carried out duly.
• Ensure proper functioning and running of QC laboratories (Chemical, sensory, microbiology, retain sample room) in accordance with ISO9001, 5S, lean principle, ISO14000 and OSHAS 18001 standards and procedures.
• Assist and support in the implementation of continuous improvements in QA/QC functions

Qualification

• Minimum Diploma or Degree in Chemistry, Food Science and Technology, Analytical Chemistry or equivalent in years of similar experience.
• Overall work experience of 1 to 3 years in a similar position.
• Basic knowledge & interpretation of gas chromatography, knowledge of densimeter and refractive index equipment preferred.
• Basic knowledge of chemistry.
• Basic Sensory evaluation capability / potential capability preferred.
• SAP knowledge will be an advantage

his position is part of the Quality Control Department reporting to the QC Manager and will be located in Benoi, Singapore.

In this role, you will have the opportunity to:

• Carry out day-to-day testing including preparation of standards and samples and escalating the failed and risky products.
• Support plant initiatives on PSP, 5S, ESH, Engagement and Kaizen.
• Support to drive lab vision, ensure execution of lab vision to meet company business and production requirement.

The essential requirements of the job include:

• Minimum ITE/ Higher Nitec/ Diploma in related Science.
• Ability to read/write in English.
• Computer skills – Excel, Word, Typing and Data entry skills.
• Working in 8 hours shift in a cleanroom environment with the gowning procedure.

It would be a plus if you also possess previous experience in:

• Exposure experience to ICP-MS / GC-MS / Liquid Particle Counter/ TOC.
• Good understanding of GMP, GDP, GLP and Quality parameters in QC operations.

Pall Corporation, a Danaher company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at danaherbenefitsinfo.com.

This position is part of the Quality Control Department reporting to the QC Manager and will be located in Benoi, Singapore.

In this role, you will have the opportunity to:

• Carry out day-to-day testing including preparation of standards and samples and escalating the failed and risky products.
• Support plant initiatives on PSP, 5S, ESH, Engagement and Kaizen.
• Support to drive lab vision, ensure execution of lab vision to meet company business and production requirement.

The essential requirements of the job include:

• Minimum Diploma in related Science.
• Minimum 3 years of experience in routine QC operations.
• Ability to read/write in English.
• Computer skills – Excel, Word, Typing and Data entry skills.
• Working in 8 hours shift in a cleanroom environment with the gowning procedure.

It would be a plus if you also possess previous experience in:

• Exposure experience to ICP-MS / GC-MS / Liquid Particle Counter/ TOC.
• Good understanding of GMP, GDP, GLP and Quality parameters in QC operations.

Pall Corporation, a Danaher company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at danaherbenefitsinfo.com.

Purpose

To provide an effective testing and analytical service to the plant ensuring that products manufactured are tested to specification on time and plant quality and safety goals are met. Ensure that all raw material, in-process and finished product testing and method transfer testing is carried out per schedule and per GMP. Ensure that records are maintained to appropriate requirements.

• Perform biochemistry, analytical and raw material of in-process and marketed products for lot release in accordance with quality standards and procedures.
• Responsible for housekeeping duties in the lab. Perform Quality Tag Out for laboratory equipment such as freezer, water bath and etc.
• Support laboratory operations including but not limited to method transfer, equipment qualification, calibration, cleaning and maintenance, purchase and receipt of reagents and consumables, waste management, reagent and media preparation, critical reagent management and document management.
• Review lot release data, identify testing discrepancies and participate in laboratory investigations.
• Participate in inspection and ensure that the laboratory and documents are in a constant state of regulatory compliance and inspection readiness.
• To assist in writing SOP documents, Change plan or change records (document revisions) supporting continuous improvement of test procedures and assay sheet design.
• To carry out completion and review of GMP Documentation of data sheets or LIMS software.
• To carry out QC sample receipt, assay and release procedures.
• Support Audit preparation and any audit related activity.
• Reading and understanding the test procedure and the requirements per USP, JP and EP.
• Require to perform 12 hours shift work.

Qualification and experience

• Bachelor of Science majoring in Chemistry, Biochemistry or related scientific degree.
• More than 2 years relevant experience, preferably in the bio-pharmaceutical / Pharmaceutical industry.
• Good working knowledge of cGMP and regulatory requirements related to Quality is preferred.
• Problem-solving and troubleshooting skills.
• Highly motivated and independent.
• Possess good interpersonal and communication skills.
• Knowledge of cGLP / cGMP, FDA, EMA and ICH guidance’s and industry standards for analytical development and characterization.

his position is part of the Quality Control Department reporting to the QC Manager and will be located in Benoi, Singapore.

In this role, you will have the opportunity to:

• Carry out day-to-day testing including preparation of standards and samples and escalating the failed and risky products.
• Support plant initiatives on PSP, 5S, ESH, Engagement and Kaizen.
• Support to drive lab vision, ensure execution of lab vision to meet company business and production requirement.

The essential requirements of the job include:

• Minimum ITE/ Higher Nitec/ Diploma in related Science.
• Ability to read/write in English.
• Computer skills – Excel, Word, Typing and Data entry skills.
• Working in 8 hours shift in a cleanroom environment with the gowning procedure.

It would be a plus if you also possess previous experience in:

• Exposure experience to ICP-MS / GC-MS / Liquid Particle Counter/ TOC.
• Good understanding of GMP, GDP, GLP and Quality parameters in QC operations.

Pall Corporation, a Danaher company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at danaherbenefitsinfo.com.

This position is part of the Quality Control Department reporting to the QC Manager and will be located in Benoi, Singapore.

In this role, you will have the opportunity to:

• Carry out day-to-day testing including preparation of standards and samples and escalating the failed and risky products.
• Support plant initiatives on PSP, 5S, ESH, Engagement and Kaizen.
• Support to drive lab vision, ensure execution of lab vision to meet company business and production requirement.

The essential requirements of the job include:

• Minimum Diploma in related Science.
• Minimum 3 years of experience in routine QC operations.
• Ability to read/write in English.
• Computer skills – Excel, Word, Typing and Data entry skills.
• Working in 8 hours shift in a cleanroom environment with the gowning procedure.

It would be a plus if you also possess previous experience in:

• Exposure experience to ICP-MS / GC-MS / Liquid Particle Counter/ TOC.
• Good understanding of GMP, GDP, GLP and Quality parameters in QC operations.

Pall Corporation, a Danaher company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at danaherbenefitsinfo.com.

Responsibilities:

• Conduct sensory evaluation of incoming and new raw materials and production products.
• Manage the overall QC status and approval of all incoming and new raw materials, intermediate and final products, including SAP transactions to facilitate shipment.
• Carry out the physiochemical analysis for sample laboratory samples.
• Issue various documents and reply technical enquiry raised internally or externally (e.g by customers).
• Conduct investigations on customers’ complaint samples or rejected items (Internal & External).
• Ensure lab stock is sufficient for lab use.
• Ensure preventive maintenance and external calibration of lab equipment is carried out duly.
• Ensure proper functioning and running of QC laboratories (Chemical, sensory, microbiology, retain sample room) in accordance with ISO9001, 5S, lean principle, ISO14000 and OSHAS 18001 standards and procedures.
• Assist and support in the implementation of continuous improvements in QA/QC functions.

Qualifications:

• Minimum Diploma or Degree in Chemical Process Technology, chemistry (preferably in Food Technology) or equivalent in years of similar experience
• Basic sensory skills
• Basic Chemistry