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  • Location

    Amsterdam , Netherlands

  • Job title:

    QP/ QA Manager

  • Sector:

    Pharmaceutical

  • Job ref:

    44159

  • Startdate:

    2020-05-28

QP/ QA Manager

The organization
Our client manufactured and market pharmaceutical formulations and active pharmaceutical ingredients.

Role description
You are responsible for QP batch certification as per 2001/83/EC. You ensures that activities at Contract Manufacturing Organizations are conducted according to the relevant Standard Operating Procedures aligned with the Quality Assurance Agreement. 

Responsibilities

  • Ensure quality oversight of manufacturing operations at the CMOs.
  • Review and approval of change control notification received from third parties 
  • Manages all quality issues associated with the manufacturing, testing and release of Drug Products or Medical Devices originating from assigned CMO´s.
  • Review and approval of annual product review (APR/PQR).
  • Ensure negotiation and maintenance of Quality technical agreements with assigned CMOs.
  • Ensures the sites used as third parties for manufacturing testing and storage of API and medicinal product are maintained in a qualified state by planning and executing external audits.
  • Ensuring that the distribution of medicinal products complies with Good Distribution Practice
  • Main point of contact for all QA related topics intern and externally.
  • Participate authorities’ inspections towards the maintenance of the MIA of the site.
  • Ensure local QMS is maintained up to date in accordance with Global standard policies, relevant regulations, new trend and industry standard.
  • Support of Quality KPIs generation and trending as support for periodic Quality management review board.
  • Ensure timely escalation to management of key quality issues while bringing proposals for resolution and impact mitigation in line with corporate standard and relevant local regulation.
  • Preparation and execution of GMP/GDP training for employees.

Requirements

  • BSc and MSc in (Bio) Chemistry, Pharmacy, Biotechnology or similar education.
  • Minimum of 5 years of relevant experience in GMP regulated environments.
  • Minimum of 3 years in quality assurance departments.
  • Medical Device experience and knowledge.
  • Experience as Qualified Person for minimum of 2 years.
  • Strong knowledge of EU GMP, US CFRs.
  • Preferred additional experience in drug product sterile pharmaceutical manufacturing is an asset.
  • Fluent in English.

If you are interested in this role, please contact me at e.wienen@sire-search.com or at +31 20 658 98 00.

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