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Contract: Q Associate 30402 / The Netherlands

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Added:2021-01-22
Location: Breda, North Brabant, The Netherlands
Salary:Negotiable
Duration:Contract
Apjid3

The client are looking for a QA Associate in the Breda area on an initial 12 month contract with the potential to extend.

Please note that this is a 3 shift cycle role


Main Responsibilities of the role

  • Provide daily guidance and support to Production staff in regards to compliance with Standard Operating Procedures and Work Instructions.
  • Act as a first point of contact in case of production queries (quality related) during packaging and labeling operations.
  • Review and approve batch production record data entries before production activities take place
  • Perform finished product checks during (commercial) production runs
  • Compile and review batch records for lots assembled, packaged and labelled and contract manufacturers in preparation for disposition by QP.
  • Review of operational SOP's and Work Instructions as needed
  • Review and approve deviation records
  • Initiate and own QA deviations as needed.
  • Perform GMP compliance checks in production
  • Assist in development and delivery of GMP training activities for QA and production staff
  • Participate in QA production related projects as needed
  • Assist in various investigations as needed
  • Assist in projects and improvement efforts as needed
  • Responsible for preparation of weekly/monthly metrics
  • Own and maintain departmental performance boards

Desired Experience and Background of the successful candidate

  • MBO or Bachelor's degree in Life Sciences or related field or the equivalent combination of education and/or experience.
  • Typically 3 years of related Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry with experience in batch record review and investigations.
  • Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and/ or Good Clinical Practice (GCP) knowledge with the ability to interpret and apply in mainly routine cases.
  • Manufacturing and/or Quality analytical processes and operations.


How to Apply









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