Senior Quality Assurance Manager / QP Pharmacist
İlan açıklaması
On behalf of our client—a leading global biotechnology and pharmaceutical company—we are seeking a Senior Quality Assurance Manager / QP Pharmacist to be based in Ankara. This role will play a key part in a strategic localization and technology transfer project in Türkiye.
Oversee and manage the technology transfer of manufacturing and quality management systems (GMP) from the global facility to the local site in Türkiye, ensuring compliance with all applicable regulations and quality standards.
Review and approve all quality-related technical documentation, including Technology Transfer Manuals, batch records, validation protocols, and reports.
Serve as the Qualified Person (QP / Legally Responsible Pharmacist) to assess and certify that plasma-derived medicinal products meet all quality, safety, and regulatory standards prior to batch release for patient use.
Ensure compliance with Turkish Health Authority (TITCK) regulations and international guidelines, serving as the key contact for health authority liaison and audits.
Help establish quality assurance and quality control infrastructure from the ground up and lead local quality operations.
nitelikler
Education: Bachelor’s Degree in Pharmacy (eligible to act as Qualified Person / Responsible Pharmacist under Turkish regulations).
Experience: 5+ years of experience in Quality Assurance (QA), Quality Control (QC), and GMP within the Pharmaceutical or Biotechnology industry.
Leadership: Minimum 3+ years of team management or leadership experience.
Tech Transfer: Hands-on experience in technology transfer, validation, and quality management systems.
Regulatory Knowledge: In-depth knowledge of TITCK regulations and international pharmaceutical standards.
Language: Fluent in written and spoken English andTurkish.
Location: Based in or willing to relocate to Ankara.
Mindset: Adaptable and proactive, with the flexibility required during early-stage organizational setup and project implementation.
İlan özeti
- Ankara konumunda yayımlanmıştır.
- Sektör: Diğer. Çalışma bilgileri: Tam Zamanlı.
- Başvuru, ilan sahibinin veya kaynak sitenin başvuru sayfasında tamamlanır.
Aranan nitelikler
Education: Bachelor’s Degree in Pharmacy (eligible to act as Qualified Person / Responsible Pharmacist under Turkish regulations).
Experience: 5+ years of experience in Quality Assurance (QA), Quality Control (QC), and GMP within the Pharmaceutical or Biotechnology industry.
Leadership: Minimum 3+ years of team management or leadership experience.
Tech Transfer: Hands-on experience in technology transfer, validation, and quality management systems.
Regulatory Knowledge: In-depth knowledge of TITCK regulations and international pharmaceutical standards.
Language: Fluent in written and spoken English andTurkish.
Location: Based in or willing to relocate to Ankara.
Mindset: Adaptable and proactive, with the flexibility required during early-stage organizational setup and project implementation.
Bu ilan Randstad Türkiye kaynağından alınmıştır. Başvuru, ilan sahibinin sayfasında tamamlanır.