Validation Supervisor
DEMO SA is one of Europe’s leading pharmaceutical manufacturers. We are expanding with new state-of-the-art manufacturing facilities in Tripoli, Arcadia. All roles below are full-time, on-site (day shift) at the new plant, with occasional trips to Kryoneri for training.
About the role
As a Validation Supervisor, you will lead the site Validation program across equipment, utilities, cleanrooms and processes, ensuring Annex 1/15/11 compliance and governing the site Contamination Control Strategy (CCS) and Validation Master Plan (VMP).
Responsibilities
- Lead and develop the Validation team; plan resources, training and competence development.
- Own the site VMP, validation schedule and re-qualification/calibration plans; monitor KPIs and report to senior management.
- Approve URS, risk assessments and DQ/IQ/OQ/PQ protocols and reports; ensure alignment with lifecycle PV (PPQ/CPV).
- Oversee FAT/SAT execution, discrepancy/deviation closeout, change control and audit/inspection readiness.
- Ensure robust QRM practices per ICH Q9 (R1); chair risk reviews and drive risk-based decision making and subjectivity controls.
- Govern CSV/CSA approach for GxP computerised systems in line with EU Annex 11 and GAMP 5 (Second Edition).
- For sterile operations: lead Annex 1 compliance (CCS, EM strategy and trending, barrier technologies, aseptic risk controls).
- Cross-functional collaboration with Production, Engineering, QC/QA to ensure timely, compliant project execution.
Employment Type
Permanent, on-site (day shift) at DEMO SA’s new manufacturing plant in Tripoli, Arcadia. Occasional trips to Kryoneri for training.
Requirements
- BSc in Engineering or related scientific field; MSc or MBA is a strong plus.
- More than 5 years in pharmaceutical validation (including sterile/aseptic), with ≥2 years in a supervisory/lead role.
- Deep knowledge of EU GMP Annex 15/11/1, FDA 21 CFR 210/211 & Part 11; strong understanding of lifecycle PV (PPQ/CPV).
- Proven leadership, project management and stakeholder communication skills.
- Fluency in Greek and English; proficiency with MS Office.
Benefits
The Company offers competitive remuneration, continuous learning and development opportunities, and a friendly and challenging working environment.