QA Specialist - QP

TECHNICUS.NL - Eindhoven

Functieomschrijving

coordinator


  • Provide daily oversight, guidance and support to Production staff in regards to compliance with Quality Policies and Procedures
  • Disposition batches labelled and packaged at ABR
  • Handle Non Conformances and CAPA’s mainly as initiator or QA-contact. Lead and assist in various investigations as needed
  • Own, review and approve SOP’s
  • Handle change control records mainly as assessor or as QA contact
  • Participate in ABR projects and improvement efforts including product launch teams
  • Partner with Production staff in performing risk analysis and the establishment of quality limits and requirements
  • Perform GMP compliance checks in production
  • Assist in development and delivery of GMP training activities for QA- and production staff

  • EU Pharmacist degree (or equivalent) is required (e.g. BIG registered)
  • Typically 3+ years of related professional experience, relevant experience in dealing with non-conformances and change control records
  • Good problem solving skills
  • Sound knowledge of Good Manufacturing Practice and Good Distribution Practice
  • Experience in (bio) pharmaceutical production environment, in particular packaging and labelling
  • Customer oriented and service minded

YER


The company leading in the field of human medicine in the biotechnology industry. For over 30 years, the company has expanded the power of scientific discoveries and innovations to significantly improve people's lives.

The company pioneered the development of new products based on advances in recombinant DNA and molecular biology and launched the first blockbusters in the biotechnology industry. At the moment, a Fortune 500 company, is committed to millions of patients, an enterprising, science-based company dedicated to helping people fight serious diseases.




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