Total 5 quality assurance job vacancies in D22 Jurong, Jurong Island, Tuas

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 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

Quality 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 incumbent will provide quality oversight on manufacturing site operations at the shop floor and co-ordinates with central quality functions as needed. The role will ensure and maintain high standards of quality and compliance within our organization.

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

• Act as a primary quality contact for assigned IPT & provide day-to-day quality support/guidance to IPT operations including quality decisions for manufacturing related events on the shopfloor.
• Represent quality at Integrated Process Team (IPT) tier meetings (example- Tier-2, Tier-4, Micro Tier), liaise with other quality functions for cascades or escalations to & from IPT Tiers.
• Review & assess events reported on the shopfloor, concur justifications to continue the operations or instruct to stop the operations while pending formal initial quality assessment.
• Participate shopfloor GEMBAs to ensure permanent inspection readiness of the site. Support audit & inspection resource room as assigned by the Manager.
• Act as a quality representative for assigned New Product Introduction (NPI) project & provide quality oversight on manufacturing of developmental batches, clinical manufacturing, process/packaging performance qualifications, equipment qualifications, certificate of analysis profile set-up, material creations, equipment & process change controls, and ensure pre-PAI readiness etc.
• Quality review & approval of documents related to development & qualification of process & cleaning, examples include but limited to - protocol & report for cleaning development cleaning validation, process development, process performance qualification, Initial Continued process verification (CPV), campaign length extensions, dirty/clean hold time changes etc.
• Quality oversight on new/revised electronic or paper documents to support routine production operations, examples include but not limited to –Production batch sheets, cleaning batch sheets, re-packaging protocols, Bill of Materials (BOM) memo, Engineering Record (ER) in IPI, Engineering Change Order (ECO) in SAP, Manufacturing Execution System (MES), non-routine Batch Sheet (BS), e-Log for Batch Sheet (BS) redline markups etc.
• Review & Approval of Statistical Process Control (SPC) limit report, Yield reports
• Perform quality review & approval of routine production/facilities related documents including but not limited to – Environment Management System (EMS) review for manufacturing, warehouse and labs, pest control review, preventive & correction maintenance (PM&CM) extension requests.
• Review non-routine/risk release of equipment/utilities/room, batch risk processing requests & support related material control actions.
• Support ad hoc requests for samples, joint inspections of rejected materials/damaged incoming goods, Time-Out-of-Cold-Storage (TOCS) adjustments in SAP, shelf-life extension requests etc.
• Perform any other tasks as assigned by Manager
• Provide quality oversight for the Aseptic Process Simulation (APS) and Aseptic Observer Program (AOP) such as quality monitoring, review and approval of APS protocol and report
• Review and approve performance qualification protocol, equipment & utilities re-qualification protocols or EM re-qualification protocols.
• Review/Approval of Re-packaging protocol for pre-execution
• Review and approve relevant Artwork.

Requirements:

• Diploma or bachelor’s degree in science/ Life Science, Pharmaceutical Science or Engineering or any other relevant field
• Minimum 5 years of applied professional work experience in quality control/assurance in pharmaceutical manufacturing environment.
• Competency in root cause analysis methods and tools.
• Experience in new product introduction or technology transfers.

Reg No: R22104540

EA License no: 94C3609