Quality Assurance Validation Supervisor
Demo S.A.
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. #J-18808-Ljbffr Demo S.A.
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