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pi is a global integrator of excellence to some of the world’s leading life science companies. From our origins as a trusted supplier of regulatory and technical support, we’ve grown to become their strategic partner of choice. We’ve grown to be bigger by learning how to be better.

pi is a global integrator of excellence to some of the world’s leading life science companies.

Quality Assurance Specialist

Vaktechnisch - expert
Bio ingenieur (ir.)
Industrieel ingenieur (ing.)
Consultancy op projectbasis
Onbepaalde duur
Voltijds
Nederlands
Frans
Engels
Antwerpen
Oost-Vlaanderen
Vlaams-Brabant
5 jaar
Chemie en farmaceutische industrie

Functieomschrijving

To further drive our increasing growth, we are currently looking to expand our team with a QA Specialist.

Our ideal candidate is a well-organised professional with a QA mind-set and excellent knowledge of GMP and system validation standards. Your pro-active and meticulous attitude allows you to keep a good overview. Last but not least, you have great written and verbal communication skills.

Sounds like you? Apply today and take the opportunity to work on multiple ambitious projects in the life sciences industry.

Your responsibilities:

  • You ensure the QA oversight of the continuous validation activities.
  • You take part in the implementation, the follow-up and the maintenance of the continuous validation plan.
  • You define the validation strategies through the change control process.
  • You write and implement some validation documentation.
  • You will review and approve specific qualification and validation documentation (IQ, OQ, PQ, PV).
  • You ensure the correct application of the validation quality systems on the field and define improvement plans if required.
  • You support the production & technical services teams in the implementation of the validation activities.
  • You take care of the adequate management of validation deviation and potentials CAPA.
  • You participate to external audit as appropriate.

Algemene vereisten

Desired skills and experience:

 

 

 

  • You have a Master degree in Sciences / Biological Engineering or equivalent through relevant experience.
  • Since a number of years you already have relevant experience in a pharmaceutical / biotech: medical devices environment as Engineer, Validation expert or Quality Assurance.
  • Experience in Pharmaceuticals is a strong asset.
  • You have knowledge of GMP, 6 Sigma methodology and risk management tools like FMEA.
  • You are familiar with documentation and writing validation documents.
  • You are able to multitask and know to prioritize.
  • You work independently and operate within a team concept.
  • You can drive and motivate a team.
  • You are a good planner and an analytical problem solver.
  • You are a fluent communicator with a professional knowledge of Dutch and English (written and oral) and provide the necessary assertiveness

Aanbod en voordelen

It is essential that each new team member fits our corporate values and culture. We believe in an open and collaborative workplace where transparency is paramount. We encourage creativity, challenge accepted best practices and focus on internal knowledge. But most of all, we hold integrity and honesty in high regard. To us, mutual respect and focus on total client satisfaction is the key to long-term growth.

 

 

 

Our offer includes a highly competitive remuneration program, including multiple supplementary benefits. You will have the chance to shape your own career and to further grow your professional expertise.

 

 

 

Apply today and become part of an ambitious team of experts with a focus on people, quality and knowledge.

Sollicitatieprocedure

Please send your resume to nhoste@3-14.com and we will get in touch!