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Specialist - QA Ops - Manufacturing Mgmt



Operations, Quality Assurance
Posted on Tuesday, December 12, 2023

About the Role

Location – Singapore #LI Hybrid
About the Role:
This role support/provide quality oversight in ensuring a smooth manufacturing operation, new product launches/transfer in a compliant/timely manner, drug substance batch review/release are in full gmp compliance to regulatory standards and ensures quality strategy/continuous improvement are executed in alignment to site objective/s.
Key Responsibilities:

• Ensure all activities in compliance with cGxP, incl. data integrity
• Review and approval of analytical data / tests (analytical release)
• Oversight of all production and testing activities, ensures compliance with cGxP, incl. data integrity and eCompliance
• Support exception investigations
• Review and approval of production, QC, and AS & T records
• MBR review. Support OpEx improvement projects. Executes batch release in compliance with registration (if Qualified Person)
• Comply with all HSE guidelines. Detect and report potential accident, risks and propose solutions
• Participate in HSE risk assessments. Preparation and participation to internal HSE audits