Total 6 support advisor job vacancies in Quality Assurance / Control category in D04 Harbourfront,Telok Blangah, Sentosa Island

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

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

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

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 & Requirements

Our Quality group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

What will you do

• Responsible for planning, scheduling and performing calibration, maintenance and qualification of laboratory equipment.
• Responsible for maintaining laboratory chemicals and consumables inventories and disposals.
• Responsible for archival/retrieval of retention samples.
• Ensure laboratory equipment calibration, maintenance and qualification within timely manner and in compliance to standard operating procedures with necessary laboratory safety precautions.
• Liaise and coordinate with external service providers in carrying out calibration, maintenance and qualification of laboratory equipment and tools.
• Liaise with external vendors to ensure chemicals and consumables supply continuity.
• Support laboratory investigation on laboratory equipment failure, Out of Tolerance and Out of Specification
• Be the subject matter expert of laboratory maintenance and participate as auditee in site internal audit/external audit.
• Coordinate with laboratory team to ensure equipment availability for calibration, maintenance and troubleshooting work.
• Manage archival/retrieval of record for laboratory calibration, maintenance and qualification related documents.
• Understand customer needs and identifies solutions to non-standard requests by interpreting existing procedures, processes and practices.
• Ensure work and behave in accordance with EHS procedures and guidelines.
• Maintains positive working relationships among employees and fosters an environment where employee engagement, empowerment, teamwork and accountability are the cultural norm.
• Participate in continuous improvement initiative as part of the production system culture in Singapore.
• Participate in EHS, Business Compliance, cGMP and all other compliance-related matters, where applicable.
• Uses formal data based analytical tools (such as Lean Six Sigma process) to identify and implement operating improvement opportunities to eliminate waste, improving accuracy, compliance and productivity.
• Any other duties as assigned by the Senior Manager/Director.

What you must have

To be successful in this role, you will have:

QUALIFICATION:

Bachelor Degree in Science/ Life Science, Pharmacy, Pharmaceutical Science or Engineering or proven relevant experience.

EXPERIENCE:

This is a career conversion programme under Workforce Singapore (WSG) and candidates must meet the following criteria:

• Singaporeans/Singapore PRs only
• PMETs/Mid-Careerist with no prior work experience in Biopharma industry are welcomed to apply
• Open to two years contract
• Minimum 2 years of relevant experience in GMP manufacturing environment, preferably laboratory operations.

QUALIFICATION:

Bachelor Degree in Science/ Life Science, Pharmacy, Pharmaceutical Science or Engineering or proven relevant experience.

Expertise, Professional and Functional Competencies

· A continued improvement mindset.

· Good knowledge and understanding of GMP

· To be familiar with simple statistic to apply statistical analysis and process control techniques.

· Experience in MS-office applications.

· Proficient in English.

Other Personal Attributes:

· Good organization and time management skills.

· Able to work independently.

· Meticulous with high integrity.

· Good interpersonal and communication skills, with ability to work in cross-functional teams.

· Continuous improvement mindset.

· Positive attitude and self-motivated.