At DEMO SA, one of the world's largest pharmaceutical manufacturers in injectable facilities, we are looking for a talented candidate for the position of Quality Assurance Officer for the Quality Assurance Validation and New Facilities Department. The position reports to the Quality Assurance Supervisor and is based in Athens.
- Prepares or/and executes the URS documentation, the qualification, validation protocols and the reports and any other procedures related to the new facilities quality system’s design, the credibility of which must be validated due to their criticality.
- Issuance/revision of QA procedures related to planned activities.
- Confirmation that the production areas as well as the rest of the supporting areas in a new facility, comply fully with the current legislation, the standards, and the internal Procedures, reviewing the Corrective/Preventive Actions that refer to Internal Audits.
- Ensures projects are managed in conjunction with all regulatory requirements (FDA, Part 11).
- Ensures the validation status of equipment and systems are always following cGMPs.
- Execution of requalification for all critical equipment according to VMP.
- Execution of calibration of all critical instruments according to CMP.
- Bachelor's degree in Engineering, Physics or a related scientific discipline. MSc degree would be considered a plus.
- At least 1 year of relevant work experience in industrial production. Relevant experience in Validation of pharmaceutical production in injectables is preferred.
- Experience in risk management tools. (FMEA, FMECA, FTA, HACCP)
- Experience in Cleaning Validation, Process Validation and Facility design.
- Experience in Qualification of pharmaceutical equipment (IQ, OQ, PQ etc.)
- Good understanding of FDA regulations, Part 211 regulations and pharmaceutical industry standards.
- Very good knowledge of MS Office.
- Excellent verbal and written communication in Greek and English.
- Ability to manage multiple tasks and set priorities to meet manufacturing deadlines.
The company offers competitive compensation, continuous training & career development opportunities and a friendly working environment.