Supplier Audit Specialist (Pharmaceutical)

About the role

We are seeking a Supplier Audit Specialist to join a leading independent contract manufacturing organization in the pharmaceutical sector. The role is based at the company’s production facility and involves planning, executing and following up on supplier audits to ensure compliance with global quality standards.

Key responsibilities

• Develop and maintain an annual, risk‑based supplier audit plan, allocate resources and prepare audit agendas.
• Conduct on‑site audits of raw‑material suppliers, service providers and subcontractors, and produce detailed audit reports.
• Manage corrective and preventive action (CAPA) processes, monitor implementation and verify effectiveness.
• Support supplier qualification and re‑qualification activities, track supplier KPIs and assist in resolving quality disputes.
• Contribute to the revision of SOPs, audit procedures and support internal, customer or regulatory audits.

Required profile

• Bachelor’s degree in Pharmacy, Chemistry, Biology, Chemical or Biomedical Engineering or related field.
• Minimum three years of active experience in pharmaceutical quality assurance and supplier auditing.
• Fluent English communication skills, both written and spoken.
• Willingness to travel up to 40 % nationally and internationally.
• Ability to work in a manufacturing environment, wear PPE and adapt to cross‑cultural settings.

Required skills

• Strong knowledge of GMP, GDP and ICH guidelines.
• Experience with ISO 9001, ISO 13485 quality management systems.
• Risk‑based audit methodology and CAPA management.
• Statistical process control and data analysis.
• Proficiency with MS Office applications.
• Lead Auditor certification (GxP, ISO 9001) – preferred.