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QP / QA Manager (clinical trials)

Meer details
Match criteria
Regio
  • Noord-Brabant
Gewenst aantal uren
  • 36 - 40 uur
  • ,
  • 32 uur
Opleidingsniveau
  • MSc
  • ,
  • PhD (+)
Functiegroep
  • Quality Assurances QA
  • ,
  • Scientific Management
Dienstverband
  • Vast

Responsibilities?

As the Managing QP / QA manager you are responsible for all quality related aspects for clinical drug product approval, including overseeing regulatory and laboratory quality. You are involved in from phase 1 studies scaling up and ensuring production, quality management systems (QMS) and work with CRO/CMO's meet quality guidelines.

As a QP you are the in-house expert for regulatory and quality. The company is in a scale-up phase and you are responsible to set-up and align quality procedures and protocols for manufacturing, product release, audits, QMS and also for the analytical laboratory activities.

In this Principal Qualified Person position, you supervise three (lab) technicians and 2 other (junior) QP/QA staff in the company. In this crucial pivotal role, you work closely with the CEO and management.

This is a permanent role, based in Oss - the Netherlands, for an experienced QP.

What are we looking for in the new QP / QA Manager (clinical trials)?

For this job, we are looking for:

  • Finished MSc (of PhD) in pharmacy, biochemistry or related field.
  • At least 5 years work experience as a Pharmacist, QP and/or analytical laboratory manager within the (bio)pharmaceutical industry.
  • Registered and licensed Qualified Person in the Netherlands (must)
  • Quality and regulatory experience of current EU GMP/ICH guidelines
  • Good technical and preferably some laboratory experience and expertise
  • Good command in English and preferably also Dutch.

What can you expect from this company?

This company provides high innovation in a fast paced environment. Their product is on a fast track to market and promises to be a game changer in the market. You will be part of a dynamic, hard-working team with a clear goal and future perspective.

Employment benefits QP / QA Manager (clinical trials)

  • Permanent position
  • Full-time
  • Salary between € 5000 - 9000 per month, depending on experience level
  • Challenging work environment

* laboratorium, qualified person, apotheker, quality assurance, GMP, GLP, GcP, ICH, responsible person

Locatie

Oss

Publicatiedatum

20.09.2022

Contactpersoon

Dirk Burgmans

Medewerkers
Dirk Burgmans
Werk telefoon: +31 20 3032 120
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