QA Specialist

Location Leiden
Discipline: Biotechnology, Pharmaceutical
Job type: Temporary/Freelance
Contact name: Merel van Os

Contact email: m.vanos@panda-int.com
Job ref: 20206
Published: 29 days ago
For this world-renowned Biopharmaceutical client, I am looking for a QA Specialist, with experience in manufacturing/production. In this position you will provide support to the QP through review of batch and validation documentation, completion of release packages, and management of routine issues.

RESPONSIBILITIES
  • Interact with Internal Quality Assurance Managers and External Manufactures to perform batch record review and complete release packages for global markets.
  • Evaluate batch manufacturing records, deviations, and associated CAPA plans and identify issues which may impact the quality of the product or the compliance to marketing authorizations.
  • Independently resolve minor issues
  • Consult with the account manager as needed for resolution of major issues
  • Ensure that all relevant QA related concerns at external manufacturing sites are raised to Janssen management.
  • Ensure Janssen specific manufacturing operations external manufacturing sites are executed in a compliant manner
  • Proactively identify risks and potential issues and delays in market release, and where possible, drive resolution. 
  • Extensive (> 3 y) knowledge of GMP, specifically parenteral experience is preferred (QA and/or production)
  • Able to connect easily, team worker, able to manage across cultures

PROFILE
  • A minimum of 8 years working in an FDA or similar regulated environment; Quality Assurance experience preferred
  • A minimum of 5 years’ experience working with pharmaceutical GMPs, specifically biopharmaceutical experience is preferred (QA and/or production)
  • Able to build connections with stakeholders, and manage across cultures
  • Strong interpersonal and written/oral communication skills
  • Proficient in applying process excellence tools and methodologies

PRACTICALITIES
  • Startdate: 01-02-2023 (flexible)
  • Duration: until end of year, with chance of extension
  • Travel: 25%
  • Language: English mandatory, other languages are a benefit

INTERESTED?
If you are interested in the above description, please apply with your CV. For more information, please contact Merel van Os on +31 (0)20 20 44 502 or by e-mail at m.vanos@panda-int.com