Supplier Audit Specialist (Pharmaceutical)
Human Kapital İnsan Kaynakları ve Danışmanlık Hiz.Ltd. · Tekirdag
Job description
About the role
We are seeking a Supplier Audit Specialist to join a leading independent contract manufacturing company in the pharmaceutical sector. The role is based at the production facility and involves managing supplier audits and quality assurance activities.
Key responsibilities
- Prepare, update, and implement annual supplier audit plans and risk‑based audit frequencies.
- Conduct on‑site audits of raw material suppliers, service providers, and subcontractors, and produce detailed audit reports.
- Coordinate corrective and preventive action (CAPA) processes, monitor implementation and verify effectiveness.
- Support supplier qualification/re‑qualification, monitor KPIs and assist in quality dispute resolution.
Required profile
- Bachelor’s degree in Pharmacy, Chemistry, Biology, Chemical Engineering, Biomedical Engineering or related field.
- Minimum 3 years of QA experience in the pharmaceutical industry with active supplier auditing.
- Fluent English (written and spoken) and willingness to travel up to 40 % nationally and internationally.
- Residing or willing to reside in Tekirdağ, Çorlu or Lüleburgaz; completed military service for males; driver’s licence preferred.
Required skills
- Strong knowledge of GMP, GDP and ICH guidelines.
- Experience with risk‑based audit methodologies.
- Understanding of ISO 9001, ISO 13485 quality management systems.
- CAPA management and document control procedures.
- Statistical process control and data analysis.
- Proficiency in MS Office applications.
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Published 6 hours ago
Expires 1 month from now
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Human Kapital İnsan Kaynakları ve Danışmanlık Hiz.Ltd.
Tekirdag