QA Manager - Anderlecht

Function Group: Quality/RA / QA Manager

Organization

For this state-of-the-art pharmaceutical company with offices in Belgium, Ireland and the UK we are looking for a Quality Manager. This belovingly company is a Belgian pharmaceutical agglomerate with focus on the distribution of medicines and the development and manufacturing of generic pharmaceutical products destined for markets worldwide. In total there are over 125 employees and counting. The group distributes a wide range of pharmaceutical products to pharmacies, wholesalers, hospitals and retirement homes. At the same time, this auspicious company is a global player on the generics market, with around 15 molecules on the European and US market and a fully stocked pipeline of niche, complex and added value products.

Function

We are looking for a Quality Manager who will be responsible for quality and safety assurance. You will do this by supervising and coordinating management programs and systems to ensure that the products meet the highest quality standards. You will be based at the site in Anderlecht. As a natural people manager, you will be responsible for a team of seven quality professionals. Everyone in the team has their own responsibilities, while one in the team is responsible for support the other is responsible for planning the audits. Because there is a very omnifarious environment with some new but also experienced employees it is very important that you have good people skills and can work with different personalities. You will get all the help and training to do so. As a manager, you are also working together with different stakeholders as RA, supply chain, procurement and R&D. This brings a lot variation and challenge. Next to the people skills it’s import that you have experience with or knowledge from different production processes, for example of a tablet or an injectable. Furthermore the following responsibilities belong to the position of the QA Manager.

  • Determines the tactical and operational direction/priorities (in conjunction with line management) for the continuous improvement of the BU QA management program and systems
  • Agrees quality agreements with external partners (contract manufacturers, logistic service providers and distributors)
  • Supports in ensuring ongoing inspection readiness in the areas of responsibilities
  • Support the internal and external audits
  • Investigates quality incidents, deviations and complaints, identify and follow-up CAPA’s and supplier improvement plans together with contract manufacturers. and ensure all documentation is updated
  • Evaluates and follow-up change controls as per company procedure
  • Agrees on stability programs and reviews stability results
  • Supports technical product transfers, qualification and validation work
  • Develops the Quality Communication Strategy for all levels of staff, to include written information, tool box talks and management briefs
  • Supports the maintenance of the Quality Management system as a SME
  • Writes product quality reviews
  • Part of supplier qualification and regular supplier auditing
  • Helps with due diligence and integration of new product developments/new product introductions
  • Assists in retaining all current quality accreditations and work towards the attainment of new quality accreditations
  • Provides support and expertise to line management in incident investigation and reporting (including dangerous occurrences and occupational diseases)
  • Identifies gaps and areas for improvement in QA processes and handling/leading remedial actions and initiatives
  • Ensures effective training programs have been implemented
  • Keeps a going awareness of new and developing regulations related to GDP’s and GMP’s

Requirements

  • Master (in pharmaceutical sciences, engineering, biochemistry, chemistry,…) or equivalent through professional experience
  • At least seven years of relevant experience in QA in the pharmaceutical industry
  • Good knowledge of the relevant European regulations for the manufacturing of pharmaceutical products
  • Good knowledge of manufacturing process for injectables and tablets
  • Knowledge of and experience in FDA regulations (US) is an asset
  • Strong project management skills
  • Speaks and writes fluently English. Other languages are an asset


Offer

  • Market conform salary starting at 70k
  • A challenging position in an international company
  • The possibility to lead a QA team
  • Plenty of abilities to work on your personal and professional development
  • Very interesting secondary benefits

Application

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

Stijn Koehler
Senior Consultant Biotech/Pharma

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

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