QA RELEASE ENGINEER

PuursIFarmaceutische industrie

Functieomschrijving

As QA RELEASE ENGINEER  you are responsible for:

  • Assure that products manufactured and packaged in Puurs and by Third Party Manufacturers to the Puurs plant meet Company and legal requirements.
  • Assure that products purchased and used in the Puurs plant meet Company and legal requirements.
  • Investigate batches not meeting specifications and prepare recommendations to the QA Manager/QA lead.
  • Coordinate cross functional investigations in case of complex root causes and work closely with Manufacturing Operations and supporting departments.
  • Evaluate root cause analysis, corrective and preventive actions and verify effectiveness in order to prevent recurring deviations.
  • Evaluate incidents that occur in the  facility of your area and prepare recommendations to the QA Manager/QA lead.
  • Operate and maintain the Quality Assurance systems.
  • Review batch related manufacturing documentation for conformity.
  • Approve master documents and SOP's.
  • Prepare Annual Product Reviews and Quality Performance Review.
  • Prepare necessary release documentation for your area.
  • Design the test plans for products in your area.
  • Support continuous improvement of products and processes through:
    • Quality deviation investigation (events/QAR's)
    • Trending of LIR, events and QARs
    • Participation in operations, product and system teams and Daily Operations Review meetings
  • Contribute to timely supply of products.
  • Release authority:
    • Product batches that meet Company and legal requirements (PQS, GMP etc).
    • Every Quality Assurance Report (QAR) needs to be approved by the Quality Assurance Lead, Manager QA, SQOL or Opu QL as described in the effective SOP.
Profiel
  • Degree: University degree in a scientific discipline, preferably in Pharmacy (QP)
  • Specific training and skills required
    • Analytical skills
    • Good communication skills, verbal and in written, in Dutch & English
    • Excellent documentation skills (technical report writing in Dutch/English)
    • Good time management and prioritizations skills
    • Human interactions (diplomacy, convincing, assertiveness, ...)
  • Nice to have
    • Preferably experience in a manufacturing environment or packaging environment
    • Experience with quality investigations and release of biological products or vaccines
Organisatie- en afdelingomschrijving

Select Projects is part of an international full-service Human Resources organization: Select HR. Select Projects specializes in offering solutions through projectsourcing. From our offices in Belgium, The Netherlands and Dubai, we provide support to companies who need experienced specialists / project staff in several areas. We distinguish ourselves by our good follow-up and service to all our customers and our employees.

For one of our pharma clients we are looking for a QA RELEASE ENGINEER

 

Aanbod

You will receive an attractive salary package with interesting fringe benefits, all in an exciting work environment where you have the ample opportunity to grow and to develop.

Heb je nog vragen?
Aartje Huybrechts Select Antwerpen 0032 36122292
QA RELEASE ENGINEER Vacature informatie
ANT011113208973
Engineering / Techniek
Projectsourcing
36-40
Wat is mijn reistijd?

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