Quality Assurance Manager - Office Hours 5 days, pharma #HDC

Quality Assurance Manager

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

Requirements:

. Min Diploma / Degree in Chemical Process Technology, Foodscience, Biotechlonogy, Biology, Biomedical Sciences, Science or its equivalents
. Min 5 years relevant experience in a related industry preferred
. Able to start immediately preferred

If you are interested in any of the positions, do kindly drop your most updated resume to [Confidential Information] (Attn: QA/ QO)

Thank You.

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