quality assurance validation supervisor
Aug 2, 2026 · DEMO S.A. Pharmaceutical Industry
What you'll do
- Lead and develop the Validation team including resource planning, training, and competence development
- Own and manage the site Validation Master Plan, schedule, and calibration/re-qualification plans
- Approve URS, risk assessments, and validation protocols and reports (DQ/IQ/OQ/PQ) ensuring lifecycle PV alignment
- Oversee FAT/SAT execution, manage discrepancy and deviation closeout, change control, and audit readiness
- Lead risk management per ICH Q9, chair risk reviews, and drive risk-based decision making
- Govern CSV/CSA for GxP computerized systems in compliance with Annex 11 and GAMP 5
- Lead Annex 1 compliance for sterile operations including contamination control strategy and aseptic risk controls
- Collaborate cross-functionally with Production, Engineering, QC/QA to ensure project compliance and timeliness
Key requirements
- 5+ years' experience
- Knowledge of EU GMP Annex 15, Annex 11 and FDA 21 CFR 210/211 and Part 11
- Leadership and project management skills with stakeholder communication expertise
- Validation Master Plan management and validation protocols (DQ/IQ/OQ/PQ)
- Risk management per ICH Q9 processes
- CSV/CSA for GxP computerized systems and Annex 1 compliance
- MS Office proficiency and fluency in Greek and English
- Engineering / Scientific field / Business Administrationpreferred
Benefits
- The Company offers competitive remuneration, continuous learning and development opportunities, and a friendly and challenging working environment.
About the job
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.
About the company
DEMO is a dynamic Greek industrial and commercial organization, specializing in the development, production and supply of pharmaceutical products.
The company is the largest supplier of injectables for public hospitals in Greece, exports 80% of its annual production and is recognized as one of the official suppliers of the United Nations, UNICEF, the World Health Organization (WHO), Doctors Without Borders and the International Committee of the Red Cross. With over 3,300 circulation licenses in 86 countries worldwide, the largest factory in SE Europe and over 1,400 employees, DEMO paves the way for pharmaceutical self-sufficiency for Greece and Europe.
Today, DEMO implements investments of €356 million, strengthening production and R&D, while entering the development and production of active ingredients and Biotechnology.
At the same time, the company is committed to ensuring equality, diversity and inclusion in the working environment and has adopted -within this context- the Diversity Charter for Greece.
DEMO moves "Always Forward" driven by its corporate philosophy of providing quality and reliable pharmaceutical products, for everyone.
About the company
DEMO is a dynamic Greek industrial and commercial organization, specializing in the development, production and supply of pharmaceutical products.
The company is the largest supplier of injectables for public hospitals in Greece, exports 80% of its annual production and is recognized as one of the official suppliers of the United Nations, UNICEF, the World Health Organization (WHO), Doctors Without Borders and the International Committee of the Red Cross. With over 3,300 circulation licenses in 86 countries worldwide, the largest factory in SE Europe and over 1,400 employees, DEMO paves the way for pharmaceutical self-sufficiency for Greece and Europe.
Today, DEMO implements investments of €356 million, strengthening production and R&D, while entering the development and production of active ingredients and Biotechnology.
At the same time, the company is committed to ensuring equality, diversity and inclusion in the working environment and has adopted -within this context- the Diversity Charter for Greece.
DEMO moves "Always Forward" driven by its corporate philosophy of providing quality and reliable pharmaceutical products, for everyone.