My client is a growing international biopharmaceutical company with multiple exiting projects on going based in the French part of Switzerland, north of Vaud canton.
Due to this current grow, my client is looking for a QA Manager to support the Quality Assurance activities associated with the start-up of a new green-field large scale API bio-manufacturing facility.
This role will lead QA Operations for DSP activities and will participate to the GMP site readiness and definition and implementation of operational processes.
This position will also support qualification activities for Downstream equipments and other process equipments as back-up.
My client is a growing international biopharmaceutical company with multiple exiting projects on going based in the French part of Switzerland, north of Vaud canton.
Due to this current grow, my client is looking for a QA Manager to support the Quality Assurance activities associated with the start-up of a new green-field large scale API bio-manufacturing facility.
This role will lead QA Operations for DSP activities and will participate to the GMP site readiness and definition and implementation of operational processes.
This position will also support qualification activities for Downstream equipments and other process equipments as back-up.
Responsabilites:
- Act as the main QA point of contact for all quality compliance key topics regarding DSP Equipment
- Act as the QA SME for DSP equipment and processes
- QA Support for Manufacturing execution System (MES) implementation in DSP
- Define Master Batch records Management process
- Review and approve MBRs
- Review executed batch records
- Support definition of batch record review process (review by exception)
- Manage deviations, CAPA and Change controls
- Support risk assessment activities including Contamination Control strategies
- Support the Commissioning & Qualification activities
- Support the creation of operational procedures,
- Contribute to suppliers auditing
- Act within compliance and legal requirements as well as within company guidelines
- Support the implementation of the bioplant manufacturing operations (GMP site readiness) as well as the associated documentation.
- Foster the understanding and the application of Good Manufacturing Practices (cGMPs) by bioplant employees
- At all times work in a right first time and site readiness approaches for regulatory inspections (Swissmedic and International)
- Contribute positively to a strong culture of business integrity and ethics
Your profile:
- Bachelor’s Degree in relevant field such as Chemical Engineering, Bio-engineering, Bioprocessing
- Speak, read and write in English and French
- Minimum of 5 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.