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Sr. Associate QA

Sr. Associate QA

LocationBreda, Netherlands
Business SectorBiotechnology
Contact nameBeata Wydurska
Contact email
Job ref22612
Published27 days ago

I’m looking for a Sr. Associate QA (working in 3 shifts) who will:

  • Provide QA guidance and support in the production area at ABR.
  • Perform batch record review of batches assembled, packaged and labeled at ABR.
  • Establish effective working relationships with Production, Warehouse, Maintenance and Engineering, QA Management and the Qualified Person.
     

RESPONSIBILITIES:

  • 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 labeled at ABR in preparation for disposition by QP.
  • Perform GMP compliance checks in production.
  • Review and approve deviation records.
  • Initiate and own QA deviations as needed.
  • Act as author for operational SOP’s and Work Instructions, as needed.
  • Review of operational SOP’s and Work Instructions, as needed.
  • 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 ABR projects and improvement efforts, as needed.
  • Responsible for preparation of weekly/monthly metrics.
  • Own and maintain departmental performance boards.

PROFILE:

  • 3 years of related QA 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.

EXTRA INFO:
We are looking for an outgoing, multi-tasking mediator with strong communication skills and the ability to work under pressure. GMP experience is a plus. Please note! This is a 3-shift job. Early shift: 06.30 - 15.00 Late shift: 14.30 - 23.00 Night shift: 22.30 - 07.00.

LOCATION: Breda

Interested? Send me your CV at b.wydurska@panda-int.com today!
Let's get in touch ASAP. Know someone interested? Introduce me to her or him. Refer a friend and earn €250,-.