Senior QMS Officer – Pharmaceutical Quality Management
Pharmathen · Attique
Περιγραφή θέσης
About the role
Pharmathen is seeking a Senior QMS Officer to lead the development, implementation, and continuous improvement of its Quality Management System (QMS) in line with EU GMP, ISO standards and other regulatory requirements. The role is based at the Marousi site and supports the broader Quality Assurance function.
Key responsibilities
- Maintain and enhance the QMS to ensure compliance with EU GMP, ISO and relevant regulations.
- Manage the document control system, including creation, review, approval, distribution and archiving of SOPs, policies and work instructions.
- Coordinate internal audits and regulatory inspections, support audit readiness and follow‑up on CAPA.
- Lead deviation and CAPA management, conduct root‑cause analysis and ensure timely corrective actions.
- Oversee change control procedures, evaluate, approve and implement changes.
- Monitor QMS KPIs, report to Quality Management and propose improvements.
- Support training on GMP, SOPs and QMS for QA and cross‑functional teams.
- Collaborate with Production, QC, Regulatory Affairs and other departments to align QMS practices.
Required profile
- Degree in Chemical Engineering, Chemistry, Biology or Pharmaceutical Sciences.
- 3‑5 years of experience in pharmaceutical quality management.
- Strong knowledge of European GMP and ability to ensure compliance with national and EU regulations.
- Excellent written and spoken English communication skills.
- Proven ability to prioritize tasks, meet deadlines and solve problems independently.
Required skills
- GMP compliance
- CAPA management
- ISO standards (e.g., ISO 9001)
- Document control systems
- Change control procedures
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Pharmathen
Attique
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