Total 58 it specialist job vacancies in Quality Assurance / Control category in SGP - Tuas South Ave 6

Posted Job Advert

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:

• Support day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for a multi-product, GxP contract manufacturing facility
• In depth awareness of entire process; identifying operational factors which influence the process
• A competent Reviewer and Approver of SOPs, protocols, reports or records
• Can trouble-shoot and able to weigh up all information and consideration in order to choose the optimum path to be taken
• Demonstrate ability to lead a small project and manage the deliverables effectively Develop good working relationships with internal & external customers
• Plan for future activities and coordinate with other departments to complete this
• Develop skills to be Qualified Trainer in area of expertise
• Able to participate actively or lead in deviation investigations, change controls and CAPA plans
• Able to lead, review and approve deviation investigations, change controls and CAPA plan as required
• Perform material release and qualification, joint inspection to identify material defect and review vendor’s investigation report as required
• Review executed batch records and logbooks and ensure that deviations are raised
• Provides Quality oversight for Operations document changes (e.g. MBRs, SOPs, Forms, Logbook, etc.)
• Provides QA oversight in any customer project related activities

Requirements:

• Bachelor's degree with 5-7 years’ experience in Quality Assurance in the Biopharmaceutical industry.
• Familiarity with Regulatory requirements and local Codes & Standards (e.g., FDA, EMEA, and ICHQ7)
• Fair knowledge and experience of the practical and theoretical requirement of quality management system in a GMP facility
• Good oral and written communication skills
• Team player, with strong focus on safety, quality and timelines
• Able to operate independently with minimum supervision for routine work within established policies and procedures and receives detailed instructions on new projects and assignments.

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.

KEY DUTIES AND RESPONSIBILITES:

• Preparation and review of qualification documents e.g., User requirement specification, DQ, IQ, OQ and PQ protocol for equipment, utilities & facility in compliance with the regulatory guidelines.
• Execution of qualification and validation activities including process, cleaning, computer system, equipment, utilities, and facility.
• Candidate must have knowledge and experience of qualification/validation principles and their practical application.
• Preparation and review of process and cleaning validation protocols and reports.
• Coordinate with the cross functional team and external service provider to meet qualification & validation schedules and maintain equipment, systems, and processes in validated state.
• Review equipment and process related change control; perform Risk Assessment to determine criticality of the proposed changes.
• Write, review, and revise validation SOPs in compliance with regulatory guidelines.
• QA oversight and/or review during the validation process.
• Manage incidents and deviations related to validation & qualification.
• Perform compliance reviews of all applicable deviations, investigations, and CAPAs related to qualification and validation.
• Review and suggest continuous improvements to the Validation Master Plan, current quality system practices, validation protocols and procedures for newly installed equipment, and overall validation strategies.
• Cross train and develop expertise in other areas of validation.
• Must be able to interact and lead effectively in a team-based environment.
• Familiarity with regulatory/compliance environment.

EDUCATION & EXPERIENCE

· Degree a scientific discipline or equivalent.

· Experience in a regulated industry preferred.

• A minimum of 5-7 years’ relevant experience in pharmaceutical manufacturing environment.

· Proficient in the use of Microsoft Word, Excel, Access, PowerPoint, and Explorer.

TO APPLY:

Candidates are encouraged to apply this position via email to [email protected] with the following information in the resume.

· Work experiences and job responsibilities.

· Current and Expected salary

· Reason for leaving.

· Date of availability

· Education background

We regret that only shortlisted candidates will be contacted.

KEY DUTIES AND RESPONSIBILITES:

· Perform analysis and tests of drug products, raw materials, in-process materials, release test samples, stability samples, packaging materials, quantitative assays on samples, and/or finished products from manufacturing, to ensure quality standards and compliance with established specifications.

· Preparation of reagents/diluents/ dissolution media as per STP.

· Perform a various qualitative tests or qualitative assays on samples using modern and automated instrumentation.

· Utilize electronic laboratory information systems such as LIMS for acquisition and processing of analytical data.

· Ensure implementation of SOP for all corresponding activities.

· Write controlled documentation related to QC Laboratory operations or testing such as SOP's, analytical protocols, analysis reports and forms.

· Ensure real time documentation, maintain data integrity and appropriate traceability.

· Assist in maintenance and calibration of test instruments per specifications.

· Responsible for the accurate, timely and compliant execution of assigned projects, analytical testing and related documentation.

· Responsible for checking all results in LIMS/RDS and reporting of any observed results that do not meet the requirement (OOS/OOT/Deviation) for further investigation.

· Destruction of expired finished products/ raw material samples as per SOP and recording the same in the register.

· Responsible for QC lab and equipment/instrument cleanliness.

· Responsible for procuring and receipt of QC lab glassware and consumables.

· Any other activities as and when assigned by the Superior.

EDUCATION:

· Degree / Diploma in science related discipline (e.g. Chemistry, Chemical Engineering).

EXPERIENCE:

· (Specialist) Minimum 4 years of quality control experience in pharmaceutical manufacturing industry.

· (Analyst) Fresh grad/ 1-2 years of quality control experience in pharmaceutical manufacturing industry.

KNOWLEDGE & SKILLS:

· Possess working knowledge of GMP in the pharmaceutical industry.

· A good team player with positive learning attitude.

· Working knowledge of validation, calibration and operation of laboratory equipment such as HPLC, GC, FTIR and Dissolution equipment.

TO APPLY:

Candidates are encouraged to apply this position via email to [email protected] with the following information in the resume.

· Work experiences and job responsibilities.

· Current and Expected salary

· Reason for leaving.

· Date of availability

· Education background

We regret that only shortlisted candidates will be contacted.

Job Description:

• Ensure the machine is working correctly, and calibrating the machine to ensure proper measuring.
• Perform incoming, in-process and final inspection as per customer requirement.
• Maintain calibration record of measuring equipment.
• Document inspection results by completing reports and logs.
• Maintain safe and healthy working environment by following standards and procedures.
• Raise non-conformance report if necessary.

Job Requirements:

• NITEC/Higer NITEC in Precision Engineering.
• 2 -3 years of relevant QC experience in a manufacturing environment and knowledge.
• Able to interpret technical/mechanical drawings of geometrical dimensioning and tolerance.
• Able to perform CMM measurement; preferably with Wenzel or Zeiss.

Job Description:

• Ensure the machine is working correctly, and calibrating the machine to ensure proper measuring.
• Perform incoming, in-process and final inspection as per customer requirement.
• Maintain calibration record of measuring equipment.
• Document inspection results by completing reports and logs.
• Maintain safe and healthy working environment by following standards and procedures.
• Raise non-conformance report if necessary.

Job Requirements:

• NITEC/Higer NITEC in Precision Engineering.
• 2 -3 years of relevant QC experience in a manufacturing environment and knowledge.
• Able to interpret technical/mechanical drawings of geometrical dimensioning and tolerance.
• Able to perform CMM measurement; preferably with Wenzel or Zeiss.

Job Description:

• Ensure the machine is working correctly, and calibrating the machine to ensure proper measuring.
• Perform incoming, in-process and final inspection as per customer requirement.
• Maintain calibration record of measuring equipment.
• Document inspection results by completing reports and logs.
• Maintain safe and healthy working environment by following standards and procedures.
• Raise non-conformance report if necessary.

Job Requirements:

• NITEC/Higer NITEC in Precision Engineering.
• 2 -3 years of relevant QC experience in a manufacturing environment and knowledge.
• Able to interpret technical/mechanical drawings of geometrical dimensioning and tolerance.
• Able to perform CMM measurement; preferably with Wenzel or Zeiss.

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

Job Description:

• Ensure the machine is working correctly, and calibrating the machine to ensure proper measuring.
• Perform incoming, in-process and final inspection as per customer requirement.
• Maintain calibration record of measuring equipment.
• Document inspection results by completing reports and logs.
• Maintain safe and healthy working environment by following standards and procedures.
• Raise non-conformance report if necessary.

Job Requirements:

• NITEC/Higer NITEC in Precision Engineering.
• 2 -3 years of relevant QC experience in a manufacturing environment and knowledge.
• Able to interpret technical/mechanical drawings of geometrical dimensioning and tolerance.
• Able to perform CMM measurement; preferably with Wenzel or Zeiss.

Job Descriptions:

• Management of CAPA from tracking, including follow-ups and closure.
• Management of Change Control, Deviations, from tracking, follow-ups and closure.
• Review quality process control plan, drive quality issues to root cause, corrective actions and improvements.
• Perform, document internal audits and other quality assurance activities to ensure readiness on international standards certification audits and GMP inspection.
• Coordinate and assists during customer visits and audits.
• Create, review work instructions and standard operating procedures, devise sampling procedures and directions for recording and reporting quality data.
• Review the implementation and efficiency of quality and inspection systems.
• Collect, compile statistical quality data, and analyze data to identify areas for improvement in the quality system.
• Review of analytical reports, and batch records (manufacturing and packaging).
• Perform SAP QM setting, review test results, block / unblock of finished products.
• Manage customer queries, customer satisfaction surveys, and questionnaires and other quality / regulatory purpose documentation requests.
• Investigate customer complaints and non-conformance issues.
• Consolidate data to create the annual product quality review report.
• Track quality performance and initiate quality improvement plans.
• Perform risk assessments and monitor risk management activities at quality level.
• Conduct /perform training to employees to improve GMP / international standards certification awareness and compliance.
• Perform any other duties and responsibilities as assigned from time to time.

Job Requirements:

• Minimum 2 years related work experience
• Possess experience in internal audit, validation activities, training management and batch release for API with good background on cGMP

Job Description:

• Ensure the machine is working correctly, and calibrating the machine to ensure proper measuring.
• Perform incoming, in-process and final inspection as per customer requirement.
• Maintain calibration record of measuring equipment.
• Document inspection results by completing reports and logs.
• Maintain safe and healthy working environment by following standards and procedures.
• Raise non-conformance report if necessary.

Job Requirements:

• NITEC/Higer NITEC in Precision Engineering.
• 2 -3 years of relevant QC experience in a manufacturing environment and knowledge.
• Able to interpret technical/mechanical drawings of geometrical dimensioning and tolerance.
• Able to perform CMM measurement; preferably with Wenzel or Zeiss.

Posted Job Advert

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 Senior QA Specialist will support day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for a multi-product, cGMP contract manufacturing facility.

Key Responsibilities:

• Oversee daily Quality Assurance (QA) operations in line with approved SOPs and policies within a multi-product, cGxP contract manufacturing environment.
• Demonstrate strong motivation and exceptional expertise across all relevant job functions.
• Competently review and approve SOPs, protocols, reports, and records.
• Participate as an active member of cross-functional site teams handling various projects and issues.
• Coordinate multiple activities across departments, ensuring seamless communication and workflow.
• Exhibit excellent troubleshooting abilities, identifying process pathways and developing strategic improvements.
• Possess advanced knowledge of cGMP topics.
• Contribute to regulatory inspections or customer audits as needed.
• Lead or support improvement initiatives and strategic process developments.
• Quickly adapt to leadership roles in various process areas as required.
• Assume supervisory responsibilities in the absence of the direct supervisor.
• Comprehend and communicate the company’s business strategy while maintaining a wide-ranging perspective on operational trends and changes.
• Provide QA oversight to QC/DS lab services, Engineering, and Validation activities, reviewing documents and Trackwise records outside routine operations. Documents may include, but are not limited to, PQR, BLA content, new product introductions, qualification/validation strategies, gap assessments, and customer suspension/decommissioning processes.
• Actively participate in or lead complex investigations into deviations, change controls, CAPA proposals, and discrepancy reports using Root Cause Analysis tools to ensure timely and effective resolution.
• Oversee the proper implementation and timely closure of CAPA related to deviations.
• Support regulatory inspections or customer audits, confidently representing the company as a subject matter expert in QA oversight.
• Offer QA oversight for site-wide improvement projects, collaborating across departments to ensure clear communication and updates.
• Lead or assist in resolving complex process and project issues.
• Mentor and coach junior team members, fostering their development.
• Formulate and present solutions to internal and external teams and management.
• Represent QA Validation/Technical Compliance in decision-making processes during internal and external cross-functional meetings.
• Complete any additional tasks as assigned by the supervisor.

Key Requirements:

• Bachelor's degree or higher in Life Sciences or Pharmaceuticals, with significant experience in Validation and Quality roles within the Biopharmaceutical industry.
• A team player with 5+ years of relevant experience in a similar industry or role.
• Thorough understanding of regulatory requirements and local codes and standards (e.g., FDA, EMEA, ICHQ7).
• Practical and theoretical experience in quality management systems within GM facilities.

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 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 QA Specialist will be responsible for performing day-to-day tasks of the QA Department in a GMP facility manufacturing clinical and commercial pharmaceutical products.

Key responsibilities:

• Monitor day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for a multi-product, cGxP contract manufacturing facility
• Highly motivated individual and have superior skills in all areas relevant to the job
• Review executed batch records and logbooks efficiently to ensure compliance with cGMP per written procedures
• Compile lot genealogy
• Participate actively and approve deviation investigations, utilizing Root Cause tools to enable effective and timely closure of deviation investigations
• Provide oversight to ensure correct implementation of CAPA based on deviation raised and ensure timely closure of CAPA
• Timely escalation of quality events on the floor based on knowledge of defined SOPs and policies
• Support changeover activities and QA on Call
• Provide training to new members and Participate in walkdown/ QA on Shopfloor and provide feedback to member of cross functional site team(s) on projects / issues
• Superior ability to troubleshoot; able to identify process pathway and work to develop improvement in strategy site team(s) on projects/ issues
• Understanding of advanced topics pertaining to cGMP
• Participate in Regulatory Inspections or Customer Audits as required.
• Identify process pathway and work to develop improvement in strategy
• Help/Transfer and quickly assimilate to leadership role in other process areas
• Assume Supervisory responsibility in absence of supervisor
• Any other tasks as and when assigned by supervisor

Key requirements:

• Bachelor Degree with relevant work experience in Quality Assurance in the Biopharmaceutical industry.
• Relevant QA Operations background from the Biopharma environment.
• Hands-on experience coordinating & interacting with internal departments on manufacturing activities.
• Fair knowledge and experience of the practical and theoretical requirement of quality management system in a GMP facility.
• Familiarity with Regulatory requirements and local Codes & Standards (e. g. , FDA, EMEA, andlCHQ7).
• Meticulous and Systematic.
• Team player, 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.

Job Description:

• Ensure the machine is working correctly, and calibrating the machine to ensure proper measuring.
• Perform incoming, in-process and final inspection as per customer requirement.
• Maintain calibration record of measuring equipment.
• Document inspection results by completing reports and logs.
• Maintain safe and healthy working environment by following standards and procedures.
• Raise non-conformance report if necessary.

Job Requirements:

• NITEC/Higer NITEC in Precision Engineering.
• 2 -3 years of relevant QC experience in a manufacturing environment and knowledge.
• Able to interpret technical/mechanical drawings of geometrical dimensioning and tolerance.
• Able to perform CMM measurement; preferably with Wenzel or Zeiss.

KEY DUTIES AND RESPONSIBILITES:

• Preparation and review of qualification documents e.g., User requirement specification, DQ, IQ, OQ and PQ protocol for equipment, utilities & facility in compliance with the regulatory guidelines.

• Execution of qualification and validation activities including process, cleaning, computer system, equipment, utilities, and facility.

• Candidate must have knowledge and experience of qualification/validation principles and their practical application.

• Preparation and review of process and cleaning validation protocols and reports.

• Coordinate with the cross functional team and external service provider to meet qualification & validation schedules and maintain equipment, systems, and processes in validated state.

• Review equipment and process related change control; perform Risk Assessment to determine criticality of the proposed changes.

• Write, review, and revise validation SOPs in compliance with regulatory guidelines.

• QA oversight and/or review during the validation process.

• Manage incidents and deviations related to validation & qualification.

• Perform compliance reviews of all applicable deviations, investigations, and CAPAs related to qualification and validation.

• Review and suggest continuous improvements to the Validation Master Plan, current quality system practices, validation protocols and procedures for newly installed equipment, and overall validation strategies.

• Cross train and develop expertise in other areas of validation.

• Must be able to interact and lead effectively in a team-based environment.

• Familiarity with regulatory/compliance environment.

EDUCATION & EXPERIENCE:

• Degree a scientific discipline or equivalent.

• Experience in a regulated industry preferred.

• A minimum of 5-7 years’ relevant experience in pharmaceutical manufacturing environment.

• Proficient in the use of Microsoft Word, Excel, Access, PowerPoint, and Explorer.

Job Description:

• Ensure the machine is working correctly, and calibrating the machine to ensure proper measuring.
• Perform incoming, in-process and final inspection as per customer requirement.
• Maintain calibration record of measuring equipment.
• Document inspection results by completing reports and logs.
• Maintain safe and healthy working environment by following standards and procedures.
• Raise non-conformance report if necessary.

Job Requirements:

• NITEC/Higer NITEC in Precision Engineering.
• 2 -3 years of relevant QC experience in a manufacturing environment and knowledge.
• Able to interpret technical/mechanical drawings of geometrical dimensioning and tolerance.
• Able to perform CMM measurement; preferably with Wenzel or Zeiss.

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.

Responsibilities:

• Support daily Quality Assurance activities in accordance with approved SOPs / Policies for a large scale, multi-product, GMP biotech manufacturing facility.
• Planning for future activities and coordinate with other departments to complete the workflow.
• Develop skills to be Qualified Trainer in area of expertise.
• Develop in depth awareness of entire process; identifying operational factors which influence the process.
• Participates in Regulatory and Customer Audits.
• Support in performing gap assessments between group documents and or regulatory guidelines
• Participate actively or lead in deviation investigations, change controls, CAPA plans and closure of discrepancy reports.
• Ensure real-time decisions on process events on the floor based on knowledge of defined SOPs & policies.
• Develops good working relationships with internal & external customers.
• A competent Reviewer and Approver of SOPs, protocols, reports or records.
• Lead a small team and provides supervision to QA Coordinators, interns or Specialists.
• Any other tasks as and when assigned by supervisor.

Requirements:

• Bachelor's degree with 2-5 years’ experience in Quality Assurance in the Biopharmaceutical industry.
• Relevant QA Operations background with experience in leading small team for projects.
• Experience in deviation investigation, change control and CAPA activities.
• Hands-on experience coordinating & interacting with internal departments on manufacturing activities.
• Fair knowledge and experience of the practical and theoretical requirement of quality management system in a GMP facility.
• Meticulous and Systematic.
• Team player, 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.

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.

Scope & Responsibilities:

• Provide guidance and direction on commissioning/qualification activities.
• Assist in change control assessments and reviews.
• Conduct laboratory computer system data integrity assessments and reviews.
• Lead the setup, configuration, and deployment of the LIMS system within the QC department.
• Work closely with QC and IT teams to ensure that the LIMS meets all operational and regulatory requirements.
• Customize LIMS workflows, forms, and reports to align with specific QC processes.
• Develop and execute qualification and validation protocols for the LIMS, ensuring compliance with relevant regulations (e.g., FDA 21 CFR Part 11).
• Perform system validation and testing to ensure the LIMS functions as intended.
• Document all qualification and validation activities in accordance with regulatory standards.

Qualifications:

• Bachelor's degree in a relevant field (Chemistry, Biochemistry, Engineering, or similar).
• Minimum of 3-5 years of experience in QC within a regulated industry (e.g., pharmaceuticals, biotechnology).
• Proven experience in LIMS implementation, configuration, and validation.
• Strong understanding of qualification and validation processes in a GMP/GLP environment.
• Proficiency in LIMS software (e.g., LabWare, STARLIMS, SampleManager) and laboratory automation.
• Excellent project management and organizational skills.

Job Description:

• Ensure the machine is working correctly, and calibrating the machine to ensure proper measuring.
• Perform incoming, in-process and final inspection as per customer requirement.
• Maintain calibration record of measuring equipment.
• Document inspection results by completing reports and logs.
• Maintain safe and healthy working environment by following standards and procedures.
• Raise non-conformance report if necessary.

Job Requirements:

• NITEC/Higer NITEC in Precision Engineering.
• 2 -3 years of relevant QC experience in a manufacturing environment and knowledge.
• Able to interpret technical/mechanical drawings of geometrical dimensioning and tolerance.
• Able to perform CMM measurement; preferably with Wenzel or Zeiss.

1. Perform analysis and tests of drug products, raw materials, in-process materials, release test samples, stability samples, packaging materials, quantitative assays on samples, and/or finished products from manufacturing, to ensure quality standards and compliance with established specifications.
2. Preparation of reagents/diluents/ dissolution media as per STP.
3. Perform a various qualitative tests or qualitative assays on samples using modern and automated instrumentation.
4. Utilize electronic laboratory information systems such as LIMS for acquisition and processing of analytical data.
5. Ensure implementation of SOP for all corresponding activities.
6. Write controlled documentation related to QC Laboratory operations or testing such as SOP's, analytical protocols, analysis reports and forms.
7. Ensure real time documentation, maintain data integrity and appropriate traceability.
8. Assist in maintenance and calibration of test instruments per specifications.
9. Responsible for the accurate, timely and compliant execution of assigned projects, analytical testing and related documentation.
10. Responsible for checking all results in LIMS/RDS and reporting of any observed results that do not meet the requirement (OOS/OOT/Deviation) for further investigation.
11. Destruction of expired finished products/ raw material samples as per SOP and recording the same in the register.
12. Responsible for QC lab and equipment/instrument cleanliness.
13. Responsible for procuring and receipt of QC lab glassware and consumables.
14. Any other activities as and when assigned by the Superior.

Job Description:

• Ensure the machine is working correctly, and calibrating the machine to ensure proper measuring.
• Perform incoming, in-process and final inspection as per customer requirement.
• Maintain calibration record of measuring equipment.
• Document inspection results by completing reports and logs.
• Maintain safe and healthy working environment by following standards and procedures.
• Raise non-conformance report if necessary.

Job Requirements:

• NITEC/Higer NITEC in Precision Engineering.
• 2 -3 years of relevant QC experience in a manufacturing environment and knowledge.
• Able to interpret technical/mechanical drawings of geometrical dimensioning and tolerance.
• Able to perform CMM measurement; preferably with Wenzel or Zeiss.

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.

As a Specialist you will be responsible for support and administration (system back-up, user access administration) for LIMS, MODA and other related Laboratory computerized systems. This role also requires to process the LIMS and MODA static data requests

Responsibilities

• Support and administration (system back-up, user access administration) for Sample Manager LIMS, MODA LIMS, iLAB, and other related Laboratory computerized systems
• Maintenance of LIMS static data (Sample Manager LIMS, MODA LIMS and STATISTICA systems)
• Support for installation and qualification/ validation of software related aspects of computerized instrumentation
• Actively contributes to operational efficiency/continuous improvement initiatives.
• Support system audit trail review all related Laboratory computerized systems
• Maintenance of software related changes to computerized instruments
• Server and database maintenance and administration as relates to laboratory systems
• Provide training for the roll-out of new computerized systems.
• Generation and execution of computer validation documentation (protocols and reports)
• Can identify computer related issues; troubleshoot, identify and complete or coordinate deviation, change control and/ or corrective action records.
• System/ equipment manufacturer and or vendor interaction as required in order to trouble shoot system issues.
• Available to troubleshoot and resolve critical system issues as they occur.
• Experience manages projects (people/ team environment) to meet the timelines.
• Customer and regulatory agency interaction as required.
• Oversight of computer system policies and procedure in order to ensure policy is aligned with current regulatory expectations.
• Familiarity with 21 CFR Part 11 and EU Annex 11 requirements, data integrity requirements and expectations as well as common industry practice with respect to laboratory computerized system management and administration.
• SME in 1 or more areas as aligned with training plan.

Experience

• Degree/Diploma in relevant Science field or Equivalent
• Minimum 5 years of experience
• Relevant work experience preferably Lab related IT experience in a biotech or medically related field.
• Experience in lab computer systems essential (prefer experience with LIMS, and CDS –Chromatography Data Systems

​

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.

R63209

Job Description:

• Ensure the machine is working correctly, and calibrating the machine to ensure proper measuring.
• Perform incoming, in-process and final inspection as per customer requirement.
• Maintain calibration record of measuring equipment.
• Document inspection results by completing reports and logs.
• Maintain safe and healthy working environment by following standards and procedures.
• Raise non-conformance report if necessary.

Job Requirements:

• NITEC/Higer NITEC in Precision Engineering.
• 2 -3 years of relevant QC experience in a manufacturing environment and knowledge.
• Able to interpret technical/mechanical drawings of geometrical dimensioning and tolerance.
• Able to perform CMM measurement; preferably with Wenzel or Zeiss.

Job Description:

• Ensure the machine is working correctly, and calibrating the machine to ensure proper measuring.
• Perform incoming, in-process and final inspection as per customer requirement.
• Maintain calibration record of measuring equipment.
• Document inspection results by completing reports and logs.
• Maintain safe and healthy working environment by following standards and procedures.
• Raise non-conformance report if necessary.

Job Requirements:

• NITEC/Higer NITEC in Precision Engineering.
• 2 -3 years of relevant QC experience in a manufacturing environment and knowledge.
• Able to interpret technical/mechanical drawings of geometrical dimensioning and tolerance.
• Able to perform CMM measurement; preferably with Wenzel or Zeiss.

1. Perform analytical equipment lifecycle management as per current regulatory requirements / SOP.
2. Involve in equipment qualification, writing URS, reporting and implementing SOP’s for system operation and maintenance, monitoring performance of the equipment and decommissioning of equipment.
3. Ensure real time documentation, maintain data integrity and appropriate traceability.
4. Support and / or perform maintenance / calibration of laboratory equipment in compliance with established schedules.
5. Liaise with vendors/service providers for PM / Calibration in a timely manner.
6. Responsible for maintenance / calibration planning of equipment within QC Department.
7. Responsible for the accurate, timely and compliant execution of assigned projects and related documentation.
8. Assist / perform method validation and transfer as required.
9. Conduct QC Department equipment operation and maintenance training to QC staff as required.
10. Perform and / or support in maintaining the asset register for equipment in the QC Department.
11. Initiate CAPEX for equipment purchase.
12. Responsible for QC lab and equipment/instrument cleanliness.
13. Any other activities as and when assigned by the Superior.

EDUCATION & EXPERIENCE:

EDUCATION: Degree / Diploma in science related discipline (e.g. Chemistry, Chemical Engineering, Biotechnology).

EXPERIENCE: Minimum 4 years of quality control experience in pharmaceutical manufacturing industry.

KNOWLEDGE & SKILLS:

1. Possess working knowledge of GMP in the pharmaceutical industry.
2. A good team player with positive learning attitude.
3. Working knowledge of validation, calibration and operation of laboratory equipment such as HPLC, GC, FTIR and Dissolution equipment.
4. Excellent interpersonal and analytical skills, good verbal and written communication skills.

Job Description:

• Ensure the machine is working correctly, and calibrating the machine to ensure proper measuring.
• Perform incoming, in-process and final inspection as per customer requirement.
• Maintain calibration record of measuring equipment.
• Document inspection results by completing reports and logs.
• Maintain safe and healthy working environment by following standards and procedures.
• Raise non-conformance report if necessary.

Job Requirements:

• NITEC/Higer NITEC in Precision Engineering.
• 2 -3 years of relevant QC experience in a manufacturing environment and knowledge.
• Able to interpret technical/mechanical drawings of geometrical dimensioning and tolerance.
• Able to perform CMM measurement; preferably with Wenzel or Zeiss.