QA Officer - Amsterdam

Vacancy information

Publication date:January 14 2020
Employment type:Permanent
Sector:Pharmaceutical
Function Group:Quality/RA

Functiegroepen: Quality/RA / QA Officer

Organisatie

For this state-of-the-art pharmaceutical company with offices in The Netherlands, Belgium, Ireland and the UK we are looking for a Quality Assurance Officer. This company is a Dutch 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.

Functie

We are looking for a Quality Assurance Officer who will be responsible for quality and safety assurance. You will do this by supervising and coordinating CMO’s, production processes and systems to ensure that the products meet the highest quality standards. You will be based at the site in Amsterdam. You will be working in 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 QA Officer, 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 Officer;


  • Assisting in the continuous improvement of the BU QA management program and systems
  • Agreeing Quality Technical Agreements with external partners (contract manufacturers, logistic service providers and distributors)
  • Supporting in ensuring ongoing inspection readiness in the areas of responsibilities
  • Supporting the internal and external audits
  • Supporting regulatory submissions
  • Investigating 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
  • Evaluating and following-up change controls as per company procedure
  • Developing and writing procedures and controlled documents
  • Reporting Quality metrics
  • Agreeing on stability programs and reviews stability results
  • Supporting technical product transfers, qualification and validation work
  • Supporting the maintenance of the Quality Management system as a SME
  • Writing Product Quality reviews
  • Part of Supplier Qualification and regular Supplier Auditing
  • Helping with due diligence and integration of new product developments/new product introductions
  • Assisting in retaining all current quality accreditations and work towards the attainment of new quality accreditations
  • Providing support and expertise to line management in incident investigation and reporting (including dangerous occurrences and occupational diseases)
  • Identifying gaps and areas for improvement in QA processes and handling/leading remedial actions and initiatives
  • Keeping a going awareness of new and developing regulations related to GDP’s and GMP’s

Functie-eisen

  • Master (in pharmaceutical sciences, engineering, biochemistry, chemistry,…) or equivalent through professional experience

  • At least four 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

Aanbod

  • Market conform salary between 60,000 – 70,000

  • 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

Sollicitatie

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

Solliciteren

Contact

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