Pharming Group N.V.

Quality Control Officer - Leiden

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Job

Active since 09-04-2018 Job category Quality / Health / Environment ...
Location Leiden Level -
Educational level Vocational / Diploma / As... Employment type Fixed term contract with option...
Hours 40 Salary -

Pharming Group N.V. is committed to the development of innovative products for the treatment of unmet medical needs. We focus on the development and production of human therapeutic proteins to provide life-changing solutions to patients.


Quality Control officer
fulltime position
based in: Leiden

Goal of the job:

Execution of QC policy regarding routine activities for QC testing and stability studies which are outsourced to third parties by Pharming Technologies and Broekman Instituut.

Job description:

QC-testing:

Support QC manager and QC Scientists in their contact to CMOs and CLOs regarding the outsourced QC-tests:

  • Review and trending of test results from CMOs and CLOs regarding the outsourced QC-tests.
  • Inform and/or report to involved departments within Pharming regarding QC related subjects: Supply Chain, QA, Manufacturing, R&D, Broekman.
  • Coordinate shipment of samples.


Stock management of reference standard and internal control for QC-tests:

  • Keeping overview of reference standard and internal control inventory at CMOs and CLOs.
  • Coordinate supply of materials for preparation of reference standard, internal control and test specific reagentia for QC tests.
  • Initiate documents for implementation of reference standard and internal control.
  • Ensure that implementation of reference standard and internal control is reported.

Support of QC manager and QC Scientists regarding stability studies of drug substance (API), drug product and starting material.

  • Review and trending of test results from CMOs and CLOs regarding the outsourced stability studies.
  • Inform and/or report to involved departments within Pharming: QA, Manufacturing, RA.
  • Coordinate shipment of samples.

 

Other Support

Support the department Regulatory Affairs when collecting information regarding QC tests and stability studies.

Qualifications:

Education:

MBO/HBO or similar, education with specialisation Biochemistry, Analytical Chemistry or similar

Experience:
1 year of experience in a (bio)pharmaceutical production- or bio-analytical environment


Additional training and knowledge:

Experience in working in a GMP environment
Good command of English, both written and spoken
Work accurately

 

Competences:

Effective communication
Persuasiveness
Decisiveness
Customer focus

Team work

Coordinating skills

Accuracy

Apply:

Please apply via our website www.pharming.com or www.pharminggroup.heeft-vacatures.nl

attn. Ms. Gabriëlle Smit.

For all recruitment agencies: don't call us, we call you!




More information
This listing is a full-time job

Job category Quality / Health / Environment / Safety
Industry / Industries Medical / Health
Region Netherlands
Keywords

Contact information

Name nienke van der Veer

Location

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