QA Engineer

Highly Competitive
  1. Permanent
  2. Good Manufacturing Practice (GMP)
  3. Switzerland
Yverdon-les-Bains, Switzerland
Posting date: 10 May 2021
37440

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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