# Quality Assurance Validation Supervisor

**Company:** [Demo S.A.](http://jobs.workable.com/companies/bfFZ3SuxMR5zjdkBWmB1yU.md)
**Location:** Tripoli, Greece
**Workplace:** on site
**Employment type:** Full-time
**Department:** Quality Assurance

[Apply for this job](http://jobs.workable.com/view/67d9a24e-f67f-4ed5-91cd-435aac3ce445)

## Description

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.