QA Engineer

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.

Job Responsibilities

• 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

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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