QA Biotech Specialist

Vor 2 Tagen

Basel, Basel-Stadt, Schweiz agap2 Switzerland Vollzeit

agap2
is a European engineering and operational consulting group founded in 2005 and specialized in the industry. We work in the Pharma, Biotechnology, Medical Devices, Energy, Infrastructure, Transportation, Chemicals, and Information Technology sectors.

As a consultant
, you will have to support our clients in the realization of their projects on site by bringing your expertise and your skills.

You are agile and eager to adapt to different work environments that will fuel your curiosity of seeing what's behind closed doors of the biggest projects of our client's portfolio.

Main tasks :

  • Maintainance and improvement of the quality system

  • Preparation of batch releases including review of batch records

  • Completion and approval of GMP documents

  • Review and approval of biotechnology process validation documents (plans, protocols, reports)

  • Management of changes (change control), anomalies, CAPA (Corrective Actions, Preventive Actions), OOS (Out of Specification), complaints

  • Quality management of subcontractors (CMOs), monitoring of subcontractor qualification

  • Creation and updating of procedures

  • Creation of annual product quality reviews (APQR)

  • Conducting internal audits/support during inspections

Your profile :

  • Industrial pharmacist, PharmD, engineering degree, master's degree in quality or in biotechnology

  • Previous experience in the biotechnology industry

  • Understanding of biotechnology production processes (USP, DSP, F&F)

  • Willingness to work in an international environment

  • Knowledge of cGMP regulatory requirements

  • English and German spoken and written mandatory

Thank you for your interest in this opportunity, please note that only the selected candidates for a first exchange will be contacted.

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