quality assurance validation supervisor
2 Αυγ 2026 · DEMO S.A. Pharmaceutical Industry
Τι θα κάνεις
- Ηγείς και αναπτύσσεις την ομάδα Validation με σχεδιασμό πόρων, εκπαίδευση και ανάπτυξη δεξιοτήτων
- Διαχειρίζεσαι το Validation Master Plan, το πρόγραμμα επικύρωσης και τα σχέδια επανεπιβεβαίωσης
- Εγκρίνεις URS, εκτιμήσεις κινδύνου και πρωτόκολλα DQ/IQ/OQ/PQ
- Εποπτεύεις την εκτέλεση FAT/SAT, κλείσιμο αποκλίσεων, διαχείριση αλλαγών και προετοιμασία για ελέγχους
- Εφαρμόζεις διαχείριση κινδύνου σύμφωνα με ICH Q9, προεδρεύεις ανασκοπήσεις κινδύνου
- Διαχειρίζεσαι CSV/CSA για GxP υπολογιστικά συστήματα σύμφωνα με EU Annex 11 και GAMP 5
- Διασφαλίζεις συμμόρφωση με Annex 1 για στείρες διαδικασίες, συμπεριλαμβανομένης της στρατηγικής ελέγχου μόλυνσης
- Συνεργάζεσαι διαλειτουργικά με Παραγωγή, Μηχανικούς και QC/QA για ορθή εκτέλεση έργων
Βασικές προϋποθέσεις
- 5+ χρόνια εμπειρίας
- Γνώση EU GMP Annex 15/11/1 και FDA 21 CFR 210/211 & Part 11
- Ηγεσία και Διαχείριση έργων
- Επικοινωνία με εμπλεκόμενους φορείς
- Διαχείριση Validation Master Plan (VMP) και Πρωτόκολλα επικύρωσης (DQ/IQ/OQ/PQ)
- Διαχείριση κινδύνου (QRM, ICH Q9) και Εκτέλεση FAT/SAT
- CSV/CSA για GxP υπολογιστικά συστήματα, Συμμόρφωση Annex 1
- Γνώση MS Office και γνώση Ελληνικών και Αγγλικών
- Engineering / Scientific field / Business Administrationκατά προτίμηση
Παροχές
- Η εταιρεία προσφέρει ανταγωνιστική αποζημίωση, ευκαιρίες συνεχούς μάθησης και ανάπτυξης, καθώς και φιλικό και απαιτητικό εργασιακό περιβάλλον.
Περιγραφή Θέσης
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.
Περιγραφή Εταιρείας
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.
Περιγραφή Εταιρείας
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.