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Senior Quality Specialist

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Diverse Quality Systems role in a growing, innovative biotech company

Het bedrijf / The company

Our client 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. They have specialized themselves in the production of protein therapeutics. Their innovative technology and processes are aimed at purification and formulation of these products. They have their 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.

De functie / The role

As Senior Quality Specialist you will improve and maintain part of the Quality Management System to ensure that the quality system at our client is compliant with EU and USA GMP legislation, guidelines and/or our clients quality expectations. You will assist, advise and train colleagues regarding GMP compliance and play a substantial role in 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 co-auditor, to determine compliance with applicable guidelines (like GMP, GLP, ISO, GDP, GCP, GVP). After some training and experience you will act as a lead auditor. 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.

Het profiel / Your profile

• bachelor’s or university degree in biopharmaceutical sciences, (bio)chemistry, engineering, or equivalent
• experience in (bio)pharmaceutical environment
• good knowledge of 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

Het aanbod / The offer

• a permanent position within Quality Systems
• a challenging role in a growing pharmaceutical company
• building/changing a QMS
• working in an international environment

Reactie / Reaction

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

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

Tenslotte ..... / Finally ....

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.

Solliciteer hier
Indien solliciteer hier u verwijst naar een ongeldig webadres, is de vacature (hoogstwaarschijnlijk) inmiddels vervuld. Attendeer FMF hierop

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Derks & Derks
Derks & Derks
Leiden, The Netherlands

Geplaatst op FMF: 27 september 2021

Branche: Farma & Biotech
Functie: QA / regulatory
Opleidingsniveau: HBO / BSc, WO/academisch / MSc, PhD
Werkervaring: 0-2 jaar, 2-5 jaar, 5-10 jaar, > 10 jaar