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
