Collins McNicholas

  

JOB TITLE

Senior QA Specialist – Biologics

 

OVERVIEW 

An exciting opportunity has become available working as a Senior QA Specialist with a global

Biotech based in the Nordics. The ideal candidate will have a GMP and a Biologics background.

 

JOB DESCRIPTION 

 

  • Working as a QA contact person with API as an area of responsibility.
  • Provide general QA expertise and support for API
  • Provide QA expertise during the investigations of Deviations or OOS; and QA approve these and their related CAPAs.
  • Support and approve Change Control records
  • Contribute to the preparation of inspections as per defined and agreed role.
  • Participate in CAPAs resolution of inspection findings.
  • QA review and approval of product specifications and master batch records.
  • Review of batch records and associated documents from API before a formal release to the next manufacturing step
  • QA review and approval of records and reports related to area of responsibility.
  • Draft, review and approval of Quality Operations SOPs and of documents from areas of responsibility
  • QA review and release of Cell Banks
  • QA approver for any quality records related to API processes

 

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