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Senior QA Specialist

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Diverse Quality Assurance role in a growing, innovative biotech company

Het bedrijf / The company

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 roll-outs. 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.

De functie / The role

In the role as Senior QA Specialist you will ensure that the quality system at Pharming Group, and for external partners and contractors is compliant with EU and USA GMP legislation, guidelines and/or Pharming’s quality expectations. You will write, implement, review, and maintain SOPs, policies and other QA-related documentation in alignment with applicable GxP guidelines. You are going to act as a trainer, coach and expert for other Quality Assurance Specialists. Besides this, you will organize meetings with BME and/or Pharming’s departments to ensure problem resolution and conducting investigations associated with deviations, Change Controls, CAPA’s, Risk Assessments, protocols and reports. You will evaluate, analyse and prepare pharmaceutical documents related to commercial starting material production, including batch records, specifications and certificates to ensure compliance with applicable guidelines and procedures. Furthermore, you will identify and communicate areas for improvement and also initiate, formulate and implement new processes and procedures within your area of expertise. Other tasks may include communicating and negotiating with contractors and suppliers, proactively proposing ideas for site improvements, performing and reviewing internal and external audits (as lead auditor) and representing the QA department in diverse projects such as the implementing SAP.

Het profiel / Your profile

• Bachelor’s degree in Biotechnology, Chemistry, Biopharmaceutics or equivalent
• 6 years of experience in a (bio)pharmaceutical environment with at least 4 years in Quality Assurance
• extensive knowledge of and experience with GMP regulations for EU and US
• strong problem analysing and solving skills
• pro-active and responsible
• team player
• good professional and interpersonal communication skills; both oral and written in English

Het aanbod / The offer

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

Reactie / Reaction

Interested? Please send your resume and motivational letter by e-mail, with reference to WS/21-027-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.

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

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Pharming Group
Derks & Derks

Geplaatst op FMF: 02 maart 2021

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