Quality Assurance Validation Engineer
1 week ago
Quality Assurance Validation Engineer
DEMO AΒΕΕ
ΑΚΟΛΟΥΘΗΣΕ
Φαρμακευτικές & Κλάδος Υγείας
Προβολή 10 θέσεων
ΑθήναΤοποθεσία
Αθήνα
πριν μία ώρα
Ημ. ανάρτησης
πριν μία ώρα
Με κάποια εμπειρίαΕπίπεδο εμπειρίας
Με κάποια εμπειρία
Πλήρης απασχόλησηΤύπος απασχόλησης
Πλήρης απασχόληση
Διασφάλιση ΠοιότηταςΚατηγορία θέσης
Διασφάλιση Ποιότητας
DEMO SA is one of Europe's leading pharmaceutical manufacturers. The role below is full-time, on-site (day shift) at DEMO SA's manufacturing plant in Krioneri, Athens. As a Validation Engineer, you will ensure compliance and quality across our sterile pharmaceutical installations, supporting the full CQV lifecycle and contributing to a robust Contamination Control Strategy (CCS).
Responsibilities- Issue Quality Risk Management (QRM) reports covering design, qualification, validation, control, and on-going monitoring of facilities through the quality system.
- Prepare or review URS, qualification/validation protocols and reports (DQ/IQ/OQ/PQ) and related procedures, ensuring credibility commensurate with criticality.
- Develop, issue and revise QA procedures (SOPs) for planned activities in the facilities.
- Lead deviation investigations across production and CQV activities; perform root cause analysis and ensure effective CAPA follow-up.
- Verify that production and support areas meet current Legislation, Standards and Internal Procedures; review and track CAPAs from internal audits.
- Execute and document FAT/SAT prior to commissioning; support change control and re‑qualification.
- Perform equipment, utilities and cleanroom qualification; execute temperature mapping for controlled areas and storage.
- Conduct and document formal risk analyses (e.g., FMEA/FMECA/FTA/HACCP) and implement mitigation measures.
- Support Computerised Systems activities in line with EU Annex 11 and GAMP 5 (Second Edition) principles (CSV/CSA) as applicable.
- Ensure ongoing validated status of equipment/systems, strict adherence to cGMP and data integrity (ALCOA+).
- For sterile operations: participate in Annex 1–compliant activities (CCS, EM qualification and trending, barrier technologies).
Requirements
- BSc in Engineering, Natural Sciences or related discipline (MSc considered a plus).
- 2 years' relevant experience in industrial production; experience in pharmaceutical validation for injectables is preferred.
- Hands-on experience with risk management tools (FMEA, FMECA, FTA, HACCP).
- Experience in Cleaning Validation, Process Validation and facility design.
- Good understanding of FDA 21 CFR 210/211, 21 CFR Part 11, EU GMP including Annex 15 (Qualification & Validation), Annex 11 (Computerised Systems) and Annex 1 (Sterile).
- Excellent command of Greek and English; strong MS Office skills.
- Critical thinking, problem-solving, flexibility; ability to manage multiple priorities and meet manufacturing deadlines.
Benefits
The company offers competitive compensation, continuous training & career development opportunities and a friendly working environment.
Σχετικά tags
validation
qualityassurance
qavalidation
validationengineer
qualityassuranceavalidationengineer
qualityassuranceavalidation
qavalidationengineer
ΠΕΡΙΛΗΨΗ ΘΕΣΗΣ
Quality Assurance Validation Engineer
DEMO AΒΕΕ
ΑΚΟΛΟΥΘΗΣΕ
Αθήνα
πριν μία ώρα
Με κάποια εμπειρία
Πλήρης απασχόληση
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