Senior/ QA Operations Executive

About This Role

A Senior/ QA Operations Executive role at GSK in Tuas, Singapore, requires 5+ years of experience in pharmaceutical quality assurance and validation with specific focus on product transfer activities, electronic batch records, and GMP compliance.

Responsibilities

• Provide QA oversight for operation implementation of product transfer activities (SOP, Batch record, Operational risk assessment)
• Provide QA oversight for implementation of electronic batch record (Manufacturing Execution System)
• Lead the team on operational readiness for PPQ
• Author, review and approve operational SOPs
• Act as QA approver for deviations, CAPAs, change controls and SOPs, ensuring timely, compliant closure
• Approve GMP drawings

Requirements

• Bachelor's degree in science, engineering or a related discipline
• Minimum 5 years' experience in pharmaceutical quality assurance, validation or related roles
• Practical knowledge of current Good Manufacturing Practice (cGMP) and regulatory requirements
• Strong knowledge of cross contamination control
• Experience in authoring and approving SOPs
• Experience in assessing impact of changes, deviations and corrective actions on validation status