QA Officer – Quality Assurance in GMP Environment

About the role

Thermo Fisher Scientific is seeking a QA Officer to join its Quality Assurance team. The role supports validation and engineering activities, ensuring compliance with GMP standards and facilitating continuous improvement.

Key responsibilities

• Review and approve equipment and process validation documents, including microbial mapping, cleaning validation, and resin reuse protocols.
• Participate actively in deviation investigations and approve quality records such as deviations, CAPAs, and audit findings.
• Maintain and endorse QA‑controlled documents within the Quality Management System and update SOPs to meet regulatory standards.
• Support change control actions, DR investigations, and CAPA processing while serving as a resource for operational areas on quality issues.

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.
• Ability to work independently, prioritize tasks, and collaborate with cross‑functional teams.

Required skills

• Strong knowledge of pharmaceutical cGMP quality systems and international cGMP regulations.
• Experience with equipment validation, process validation, and risk assessments.
• Proficient in reviewing and approving QA documentation, CAPA handling, and audit findings.

What we offer

• Comprehensive health and wellbeing benefits, flexible work arrangements, and generous leave policies.
• Access to learning and development resources through Thermo Fisher Scientific University Plus and LinkedIn Learning.
• Paid volunteer time, charitable giving programs, and a supportive, inclusive workplace culture.