Qualified Person (QP)

zaventemIIndustrie pharmaceutique

Description de fonction

As Qualified Person you will :

  • Support EU QP certification and release of both PGS and non PGS manufactured supplies.
  • Support arrangements to alleviate drug shortage, including management of unlicensed supplies and exemptions provided by the BOH. 
  • Support the licensing requirements of the MIA (As identified and declared), including adherence, maintenance and development of the associated Quality Management System, continual professional development in associated dosage forms certified and BOH inspections and enquiries.
  • Review of batch manufacturing records and other documentation associated with QC release in conjunction with QA Officers.
  • Check that batch manufacturing records comply with registered details and EU GMP standards.
  • Investigate that any differences or issues found upon review of the batch manufacturing records and rectifying problems in conjunction with relevant sites and personnel.
  • Assist in the resolution of supply chain issues, such as product shortages, competent authority notifications and represents site at senior management meetings (as required)
  • Work in partnership with internal stakeholder and functional groups supporting supply to market
  • Provide leadership in European regulations ensuring GMP knowledge of self and others within both the QA team and site is developed and applied.
Profil

As Qualified Person

  • You have a Master and you are QP Certified
  • You have 3 to 10 years experience as QP
  • You are active as QP and Familiar with Sterile environment -
  • You have experience in managing priority and high workload
  • You are eligible to act as a European Qualified Person under Belgium license (PSC= licence of zaventem/PISPI = new licence), certifying products in compliance with 2001/83/EC, 2003/94/EC and Annex 16
  • You speak fluent English and you also speak French
  • you potentially have to visit manufacturing site (possible to another country)
Descriptif de l’organisation et du département

Select Projects is part of the Select group, a collection of HR companies that put people first because Quality is Performance by Genuine People. Select Projects provides technical support to clients on a project basis. Our 220 employees in Belgium and the Netherlands support companies with their projects in various domains: Life Sciences, (petro) chemical, Construction and Rail. From our offices in Antwerp and Rotterdam we optimally support our experienced specialists so that they can deliver high quality to our customers at all times.

We are looking for a Qualifed Person (QP) for our client in Zaventem.

Offre

You get an attractive salary package with interesting fringe benefits. A company car, meal vouchers, group insurance and mobile phone subscription are possible. We ensure that you end up in a pleasant working environment with nice colleagues and opportunities to develop and further develop. Together with you, we map out a training course tailored to your future plans and needs.

Avez-vous des questions?
sanae lajlufi Select Projects +32 3 203 50 85
Qualified Person (QP) Informations offres d'emploi
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