Derks Vacature Kwaliteit

Quality Systems Specialist

Pharming Group

Diverse Quality Systems role in a growing, innovative biotech company

Offer

  • a permanent position within Quality Systems
  • a challenging role in a growing pharmaceutical company
  • an amazing opportunity to use your skills and experience
  • function aimed at continuous improvement of processes
  • working in an international environment

Position

As Quality Systems Specialist you will build and maintain part of the Quality Management System to ensure that the quality system at Pharming (including Pharming’s external partners and contractors) is compliant with EU and USA GMP legislation, guidelines and/or Pharming quality expectations. You will advise employees and managers regarding GMP compliance and leads QA-related projects. Besides this, you will write, implement, review, and maintain SOPs, policies, and other QA related documentation in alignment with applicable GxP guidelines relevant for a QMS. You will identify documents which need to be created or updated and ensure this is organized. You will also perform and review internal and external audits, as (lead) auditor, to determine compliance with applicable guidelines (like GMP, GLP, ISO, GDP, GCP, GVP). Furthermore, you will act as trainer, coach, and expert regarding compliancy with EU and USA GMP legislation, guidelines and/or Pharming quality expectations and give general GMP training to Pharming colleagues. As Quality Systems Specialist you will represent QA Systems in significant complex projects and identify compliance risks and ensure these are addressed adequately. Also, you will communicate and negotiate with contractors and suppliers, with respect to deviations, configuration, validation, implementation, and complex projects. Furthermore, you will proactively propose ideas for improvements; and provide subject matter expert reports as required.

Profile

  • bachelor or University degree in biopharmaceutical sciences, (bio)chemistry, engineering, or equivalent
  • minimum of six years of experience in (bio)pharmaceutical environment, with at least four years in Quality Assurance
  • minimum of four years of experience with GMP regulations for EU and US (GMP, GLP and GDP)
  • extensive knowledge of GMP regulations for EU and US (GMP, GLP and GDP)
  • preferably knowledge of and experience with ERP (e.g. SAP) and e-DMS (e.g. Master Control) systems
  • preferably knowledge of and experience with project management
  • required competences: initiative, persuasiveness, problem analysis, oral and written communication, decisiveness

Organisation

Pharming Group develops innovative protein therapeutics for the treatment of genetic disorders. The company is ready for further scientific, technological and product development, and additional commercial rollouts. Their lead product is Ruconest™ (Rhucin® in non-European territories), which is a recombinant human C1 inhibitor approved for the treatment of angioedema attacks in patients with HAE. They are also developing the same recombinant protein in other indications, including pre-eclampsia and acute kidney injury. Furthermore, they investigate in the clinical efficacy of this recombinant protein in COVID-19. At Pharming, they have specialized themselves in the production of protein therapeutics. Their innovative technology and processes are aimed at purification and formulation of these products. Pharming has its headquarters in Leiden, the Netherlands and is growing quickly. At this moment they are open to meet an experienced candidate for the position of Senior QA Specialist.

Response

Interested? Please send your resume and motivational letter by e-mail, with reference to WS/21-032-DD, to Djamila Hagemans: info@derksenderks.nl.

For further information, please call Djamila Hagemans at number +31 (0)33 472 80 87.

An individual assessment may be part of the selection procedure.

Our client has chosen Derks & Derks B.V. as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.

Tagged as: Life Sciences

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