Contract: Q Associate 30402 / The Netherlands

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.