DEMO S.A. Pharmaceutical one of the world's largest pharmaceutical manufacturers in injectable facilities, we are looking for a high caliber Computerized Systems Quality Management (CSV) Officer in Kryoneri.
Responsibilities
In the era of Industry 4.0, Pharmaceutical Manufacturing and Laboratory processes rely more than ever on Computerized Systems to achieve time-to-market, efficiency, product quality and patient safety standards. We are looking for a talented IT professional for the role of Computerized Systems Quality Management Officer.
Role’s main objective is the validation of Computerized Systems & software (CSV) in Laboratories & Production to ensure Quality Management and compliance with GMP (Good Manufacturing Practices) according to EMA, FDA and other Regulatory authorities standards & guidelines.
- Co-ordinates preparation of User Requirements / Functional / Design Specifications for computerized systems that support GMP-critical processes as well as of Testing & Validation Scenaria (Unit tests, UATs, Validation plans & reports, Traceability matrices) to ensure Installation, Operational & Performance Qualification (IQ/OQ/PQ), in co-operation with relevant Business Units.
- Reviews IT systems specifications & configuration for GMP-readiness to ensure they meet guidelines for Traceability, Accountability and Data Integrity.
- Co-ordinates projects for delivery of GMP-critical Computerized Systems.
- Specifies & ensures execution of processes for IT systems Access Control, Change Control, Configuration Management, Error handling, Backup & Recovery, Contingency Planning, etc.
- Contributes to the definition of future technology roadmap by identifying value-adding technology opportunities.
Requirements
- University degree preferably in Electrical/Electronic/Computer Engineering, Information Technology, Computer Science or related discipline
- Excellent communication, business correspondence & procedure documentation writing skills in both Greek and English language
- Highly detail-oriented & organized, able to work both independently and as a team player with a positive attitude
- Enthusiastic, responsive and able to take ownership of problems and provide solutions
- Knowledge of GMP standards & regulations and/or pharmaceutical Computerized System Validation (CSV) procedures will be considered a plus.
Benefits
The company offers competitive compensation, continuous training & career development opportunities and a friendly working environment.