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Supplier Audit Specialist (Pharmaceutical)

Human Kapital İnsan Kaynakları ve Danışmanlık Hiz.Ltd. · Tekirdag

New
Onsite Senior 🇬🇧 English
GMP GDP ICH guidelines ISO 9001 ISO 13485 CAPA statistical process control MS Office

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 3 saat önce

Expires 1 ay sonra

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Human Kapital İnsan Kaynakları ve Danışmanlık Hiz.Ltd.

Tekirdag