Quality Assurance Manager (Pharmaceutical/ Healthcare, Office Hours 5 Days)

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 leonleong@recruitexpress.com.sg   (Attn: QA Manager)

Thank You.

Leon Leong De Cong

R1551708
Recruit Express Pte Ltd (Healthcare & Lifesciences Division)


EA License: 99C4599