CordenPharma is a leading full-service contract development and manufacturing organization (CDMO) of active pharmaceutical ingredients (APIs), excipients and pharmaceuticals Drug Products (DP) and packaging capabilities with > 2’600 employees across the world. Our services enable pharmaceutical and biotech companies to manufacture medicines with the ultimate goal of improving people’s lives.
Our network in Europe and the US offers flexible and specialized solutions across five technology platforms: Peptides, Lipids & Carbohydrates, Injectables, Highly Potent & Oncology, and Small Molecules. We strive for excellence in supporting this network and are committed to providing the highest quality products for the well-being of patients.
The QC Analytical & Equipment Specialist will work as part of the Quality Control department ensuring products are tested and stored in accordance with cGMP. Under the direction of the QC Project & Compliance Manager, and in collaboration with the colleagues, the QC Analytical & Equipment Specialist will take care of the execution of qualification and validation for QC analytical and storage equipments. He/she will continuously strengthen quality awareness and investigate quality issues using applicable process improvement and problem solving techniques to assure successful outcomes of Company and external Health Authority inspections.
Duties and responsibilities
- >> Coordinate laboratory equipment acquisition, qualification, calibration and preventive maintenance
- >> Act as shop-floor expert in the trouble-shooting for routine, validation, qualification and stability analyses in collaboration with QC technicians and QC Supervisor
- >> Ensure the initiation, management or follow-up of change control, deviations, CAPA as appropriate
- >> Integrate cGMP requirements (deviation, investigation, non-conformities) in technical activities
- >> Participates as QC analytical or technical expert to internal team meetings of some projects as appropriate
- >> Manage and review analytical activities (within Corden Pharma Brussels or with external partners) for the different analytical methods of some projects
- >> Technical QC support during customer audits and regulatory inspections (FDA, AFMPS, others)
- >> Participate to QC optimization processes and Operational Excellence QC projects
Qualifications and skills
- >> University degree in Science with Chemical background
- >> 3 years in a similar role in the pharmaceutical industry (API is an asset)
- >> Very good knowledge of GxP in a regulated environment
- >> Knowledge of risk assessment, validation and quality systems
- >> Rigorous with excellent organization and coordination skills
- >> Flexible, able to set priorities and solution oriented
- >> Team spirit and ability to work in an interdisciplinary and international environment
- >> Strong oral & written communication skills (English & French)
- >> Excellent command of Microsoft applications (Word, Excel and PowerPoint) & working knowledge of Quality Software Systems as TrackWise® System or similar systems is an asset
What we offer
We offer a permanent contract, a competitive salary package and varied and motivating responsibilities.
Then we should definitely get to know each other. We look forward to receiving your application via the button Apply or send it to [email protected]