Quality Assurance in Production

About the role

The Quality Assurance professional will lead deviation, complaint, and change control investigations, ensuring compliance with GMP and GxP standards within the production environment.

Key responsibilities

• Lead local investigation teams for deviations and complaints, ensuring timely root‑cause analysis and CAPA implementation.
• Manage change requests in the TW system, coordinate change plans, monitor implementation, and verify evidence of completion.
• Evaluate and approve new batch record versions and revised SOPs, ILs, registers, and other GxP documents.
• Conduct internal audits, support external audits, and participate in compliance gap assessments.
• Collect quality system performance data, report indicators to QA, and drive improvement actions.

Required profile

• Graduate in Pharmacy or Chemistry.
• 3–5 years of experience in the pharmaceutical industry with solid knowledge of quality management systems, manufacturing activities, process validation, qualification, and regulatory requirements.
• Strong interpersonal skills, conflict management ability, and teamwork orientation.

Required skills

• Proficiency with MS Office (Word, Excel, PowerPoint).
• Upper‑intermediate English communication skills.