Validation Supervisor

About the role

DEMO SA, a European pharmaceutical manufacturer, is opening a new state-of-the-art plant in Tripoli, Arcadia. As 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). The position is permanent, full-time and on-site (day shift) at the new plant, with occasional trips to Kryoneri for training.

Key responsibilities

• Lead and develop the Validation team, planning 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, aligned 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 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).
• Work cross-functionally with Production, Engineering and QC/QA.

Required profile

• BSc in Engineering or a related scientific field; MSc or MBA is a strong plus.
• More than 5 years in pharmaceutical validation (including sterile/aseptic), including at least 2 years in a supervisory or lead role.
• Fluency in Greek and English; proficiency with MS Office.

Required skills

• Deep knowledge of EU GMP Annex 15/11/1, FDA 21 CFR 210/211 and Part 11.
• Strong understanding of lifecycle PV (PPQ/CPV).
• Leadership, project management and stakeholder communication skills.

What we offer

• Competitive remuneration.
• Continuous learning and development opportunities.
• A friendly and challenging working environment.