Quality Assurance / Improvement Manager (Pharma Manufacturing MNC)

Quality Assurance / Improvement Manager (Pharma Manufacturing MNC)

Key Responsibilities

1. Serve as the main Quality point of contact related to suppliers
2. Manage External site to contractual obligations relative to Quality Agreement, specifications, quality, safety and regulatory requirements
3. Review and/or approve as necessary, completed production batch records, deviations, master batch records, change controls, audits/inspections responses
4. Understand and interpret applicable GMP Regulations pertaining to manufacturing and testing activities at External site
5. Provide quality oversight of the manufacturing, testing, and release of materials at External site
6. Author and drive actionable site inspection readiness plans
7. Author inspection playbooks with External site on key risks/gaps and drive readiness efforts with External site
8. Representation at product-specific Regulatory Inspections and/or during Notified Body audits of External site, as applicable or required
9. Identify and mitigate risk at the External site
10. Monitor and communicate site performances in means of quality metrics through actionable periodic reviews and operating reviews
11. Escalate risks or roadblocks to management
12. Drive timely decision making using principles
13. Drive continuous improvements

Requirements:

1. Min Diploma / Degree in Chemical Process Technology, Food Science, Biotechnology, Biology, Biomedical Sciences, Science or its equivalents
2. Min 6 years relevant experience in a related industry preferred
3. Able to start immediately preferred

If you are interested in any of the positions, do kindly drop your most updated resume to leonleong@recruitexpress.com.sg (Attn: QA Manager)

Thank You.

Leon Leong De Cong
R1551708
Recruit Express Pte Ltd (Healthcare & Lifesciences Division)
EA License: 99C4599