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  • Location

    NOORD BRABANT, Netherlands

  • Job title:

    Senior Associate QA - Production

  • Sector:

  • Job ref:

    45219

  • Start Date:

    2021-01-01

Senior Associate QA - Production

The company


You will be working in the European Headquarters of an American Biopharmaceutical international company. This site is handling all distribution, secondary packaging and labelling activities.

Description

You will provide QA guidance and support in the production area.
That includes performing batch record review of batches assembled, packaged and labeled. You will have close contact with Production, Warehouse, Maintenance and Engineering, QA Management and the Qualified Person.

Responsibilities
  • Provide daily guidance and support to Production staff
  • Act as a first point of contact in case of production queries
  • Review and approve batch production record data entries before production activities take place
  • Perform finished product checks
  • 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
  • Participate in QA production related projects as needed
  • Responsible for preparation of weekly/monthly metrics
  • Own and maintain departmental performance boards
Requirements 
  • Masters degree in Life Sciences or related field 
  •  a completed internship or 1 year of Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry
  • experience in batch record review and investigations is a plus
  • Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and/ or Good Clinical Practice (GCP) knowledge
  • Opened to work in 3 shifts 
Other information

Are you ready to take a new step in your career? If you are interested or know someone who is, contact me and upload your CV via the apply button.
Contact Us

SIRE LIFE SCIENCES B.V.

Staten Bolwerk 1
2011 MK Haarlem
The Netherlands
+31 (0) 20 658 9800

SIRE STAFFING SOLUTIONS B.V.

Keizersgracht 440A
1016 GD Amsterdam
+31 (0) 20 658 9804

SIRE LIFE SCIENCES DEUTSCHLAND GmbH

Theatinerstraße 11
80333 München
+49 (0) 89 3803 8966

SINCERE. INTELLIGENT. RESULT-DRIVEN. EXCELLENCE.