Quality Assurance Officer

About the role

The Quality Assurance group ensures compliance with current Good Manufacturing Practices (cGMP). This position supports the Quality‑on‑the‑floor program, providing real‑time quality assistance to operational areas.

Key responsibilities

• Perform real‑time batch record reviews during manufacturing and post‑production.
• Conduct routine audits of logbooks and ensure cGMP compliance.
• Approve final QA documentation, including deviations, OOS, CAPAs, and audit findings.
• Review and approve process validation documents such as microbial mapping, resin reuse, and cleaning protocols.
• Support change control actions, deviation investigations, and risk assessments.
• Update SOPs and other quality records to meet regulatory standards.

Required profile

• Tertiary degree in Biotechnology, Biochemistry, Microbiology, Chemistry, Pharmacology or equivalent.
• Minimum 3 years experience in a GMP‑regulated environment, with at least 1 year in Quality Assurance.
• Strong written, verbal and presentation skills.

Required skills

• Knowledge of pharmaceutical cGMP quality systems and international regulations.
• Batch record review and approval.
• Audit and deviation investigation.
• Process validation documentation.
• Change control and CAPA management.

What we offer

• Comprehensive health and wellbeing benefits, flexible work arrangements and extra leave options.
• Paid volunteer time, learning and development programs via Thermo Fisher University Plus and LinkedIn Learning.
• Inclusive workplace recognized as a WGEA Employer of Choice for Gender Equality.