Are you a QA Engineer interested in working for one of the most interesting names in High-Tech Biopharmaceuticals?
A Fantastic new contract role has just opened up at one of our leading Swiss based clients offering the successful QA Engineer the opportunity to join a hard-working team working on exciting projects in the pharmaceutical sector.
- Act as the main QA point of contact for all quality compliance key topics regarding DSP Equipment
- QA lead for implementation of Manufacturing execution System (MES) implementation in DSP
- Define Master Batch records Management process
- Review and approve MBRs, specifications and Material Master data
- Support definition of batch record review process (review by exception)
- Review executed batch records
- Manage deviations, CAPA and Change controls
- Lead implementation of data integrity requirements in the DSP area
- Roll-out the process to authorise the start of GMP operations in each Site areas
- QA lead in defined risk assessment activities
- Support the implementation of the bioplant manufacturing operations (GMP site readiness) as well as the associated documentation.
- Support the creation of operational procedures,
- Contribute to suppliers auditing
- Support the Commissioning & Qualification activities
- Act within compliance and legal requirements as well as within company guidelines
- Foster the understanding and the application of Good Manufacturing Practices (cGMPs) by bioplant employees
- Contribute positively to a strong culture of business integrity and ethics
Skills and Requirements
- Bachelor's Degree in relevant field such as Chemical Engineering, Bio-engineering, Bioprocessing
- Advanced degree preferred
- Speak, read and write in English and French
- Minimum of 7 years in a Quality Assurance role in a biopharmaceutical manufacturing environment
- Thorough knowledge of biotechnology processes and manufacturing
- Demonstrated proficiency in good practice requirements cGMP as well as biopharmaceutical industry regulations and standards related to qualification and validation, including data integrity and laboratory GAMP.
- Proficiencies with the quality systems and, preferably, with business processes associated with automation and integration of testing and production systems
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.