QA Manager QP - Gouda

Vacancy information

Publication date:March 25 2020
Employment type:Permanent
Sector:Pharmaceutical
Function Group:Quality/RA

Function Group: Quality/RA / QP

Organization

For an international pharmaceutical company specialised in the development, production and marketing of high-quality veterinary products, we are looking for a QA Manager / QP. Their veterinary medicines and animal nutrition are mainly sold to veterinarians. They are active in 45 countries worldwide, with their own sales organisation in 19 different European countries. They are a growing organisation that emphasises the desire to make a difference within a pleasant working culture. This role is vacant in Utrecht.

Function

In the role of QA Specialist / QP you will support Group Quality CMO management in the definition, development, implementation and ongoing review of appropriate Key Performance Indicators (KPI’s) for senior management and monitor effectiveness across external CMO sites. You need to review the PQS (Pharmaceutical Quality System) and work with the site and Group Quality department to develop the PQS needed to manage CMO’s and operate in accordance with EU GDP requirements. As a QP you ensure that EU GDP requirements are defined and embedded in the logistics and supply chain activities. Furthermore, you need to ensure that actions are taken in a consistent, fair way with direct and indirect reports according to people policies as per local requirements. You will update the internal and external stakeholders and make sure that there is an effective cross functional communication to ensure timely identification and resolution of issues. You report and create action plans as necessary on changes in standards and on performance against standards. You maintain oversight on status of the PQS and the progress of implementation of improvement activities. Next to this you ensure situations with the potential to compromise quality is highlighted and addressed in order to assure measures for improvement and issue prevention are undertaken. You will manage the review, improve and approval of change requests, corrective and preventative actions and investigations. You need to assure the implementation and maintenance of regulatory requirements and changes in existing regulatory requirements, as well as manage/write/authorise technical Quality Agreement for suppliers and CMO`s. You will also be responsible for the execution of internal audits and maintain the site accreditations/certification.

Requirements

The ideal candidate would look like:

  • Master’s degree in Pharmacy or equivalent
  • QP registration conform article 29 directory 81/851/EEG
  • Over five years of experience in Quality Assurance
  • Extensive demonstrated pharmaceutical quality experience, including audit, batch record review, change control, complaint handling and investigations experience.
  • Thorough knowledge of pharmaceutical manufacturing, packaging, testing and distribution processes and associated global regulatory GMP/GDP requirements
  • Experience of hosting / supporting regulatory inspections, client audits and self-inspections
  • Solid understanding of the requirements of an effective Pharmaceuticals Quality System
  • Technical knowledge to support quality and validation decision making

Offer

The organisation offers:

  • Salary between €70,000 and €90,000 depending on experience
  • 31 holidays
  • Flexibility to work a day from home
  • Good secundaire benefits

Application

If you are interested in this job, or in similar ones, please feel free to contact me directly.

Stijn Koehler
Sr Consultant Biotech/Pharma

+31(0)6-82400785
+31(0)23-7548660
s.koehler@qtcrecruitment.com

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