Senior Quality Assurance Specialist – QA Operations

About the role

The Senior Quality Assurance Specialist (QA Operations) will drive a quality culture, ensure GMP compliance, and support inspection readiness across manufacturing, packaging, and labeling activities.

Key responsibilities

• Promote GMP compliance behaviors and drive a quality‑first culture at the site.
• Provide QA oversight for manufacturing, packaging and labeling of intermediates and APIs, reviewing and approving master batch records, cleaning records and QC worksheets.
• Support end‑to‑end production start‑up activities, including new product introductions, changeovers, equipment releases and tank farm monitoring.
• Lead change control, investigations and deviation management, ensuring timely escalation and resolution.
• Maintain inspection readiness, support regulatory inspections and respond to regulatory queries.

Required profile

• Bachelor’s degree in Science, Chemical Engineering or equivalent (or diploma with extensive experience).
• Minimum 4 years (or 10 years with diploma) of Quality Assurance experience in the pharmaceutical industry.
• Strong knowledge of cGMP, ALCOA+, ICH guidelines and validation principles.

Required skills

• cGMP compliance
• ALCOA+ principles
• ICH guideline familiarity
• Validation knowledge
• SAP material master data handling