QA Engineer job in Yverdon-les-Bains, Switzerland

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First Name*

Last Name*

Email*

Phone Number*

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First Name*

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Phone Number*

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Job type: Permanent

Discipline: Good Manufacturing Practice (GMP)

Location: Switzerland

This vacancy has now expired. Please see similar roles below...

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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