Deputy QP, Biologics

Highly Competitive
  1. Permanent
  2. Good Manufacturing Practice (GMP)
  3. Netherlands
Hoofddorp, Netherlands
Posting date: 25 Aug 2023

This vacancy has now expired. Please see similar roles below...

Proclinical are recruiting for a Deputy QP, Biologics to join a pharmaceutical organisation. This role is on a permanent basis and is located in Hoofddorp.


  • Handle QA batch release planning of products weekly.
  • Assist with technology transfers and process/analytical method validation actions from quality operations perspective when needed.
  • Evaluate, prepare batch document for QP batch certification of clinical trial batches, as well as guarantee proper upkeep of product specification files to guarantee compliance with INDs and IMPDs.
  • Prepare yearly product evaluations of biologics products.
  • Collaborate with the quality systems manager to assist with the QA IT systems and serve as a back-up for QA IT systems actions.
  • Other duties may be assigned.

Key Skills and Requirements:

  • Educated to a degree level in a (bio-)chemistry, pharmacy or similar field.
  • At least 5 years of experience in a pharmaceutical drug substance and/or drug product manufacturing field.
  • Expertise on EU GMP, US CFRs.
  • Computer literacy.
  • Fluency in the English language.
  • A tenure of at least 5 years.
  • Familiarity working within a pharmaceutical, sterile manufacturing setting.
  • Knowledge in manufacturing, regulatory, QA/QC, QA operation, etc.
  • Acquaintance in preparing batch release, which involves batch documentation evaluation and preparing for batch certification.
  • Prior involvement and expertise on cGMP, QC/QC and regulatory compliance such as US, EU and any other global agencies.
  • Comprehension of API/DP pharmaceutical operations, QA/QC procedures and contract manufacturing.
  • Comprehension of multifaceted change control procedures and engagement with regulatory affair procedures.
  • Comprehension of regulatory proposal processes.
  • Able to evaluate and examine and analyse technical documents and offer quality assessments on change controls, deviations and complaints.
  • Acquaintance working with electronic document management, electronic training systems and Trackwise.
  • Comprehension of risk assessment and risk management fundamentals/tools.
  • Former involvement engaging with external parties.
  • Experience interacting with external parties.

If you are having difficulty in applying or if you have any questions, please contact Ayesha Kippie at +41 615 687 995.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.