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Head Of Quality Assurance

Eingestellt von Real Staffing Group aus Frankfurt am Main

Projektbeschreibung

This is a rare opportunity to join an exciting company with the chance to develop and progress in your career to the most senior level.

As the Head of Quality you will lead and manage the strategic and operational performance of the Quality department, ensuring the successful delivery of business strategy, Key Performance Indicators (KPIs) and objectives, whilst adhering to regulatory compliance and achieving commercial success.

- Implementing and monitoring all Quality Assurance systems to ensure compliance with EU Commission Directive 2003/94/EC, covering GMP for medicinal products for human use and investigational medicinal products (IMPs) for human use.
- Coordinating MHRA inspections, Home Office inspections, Pharmacy inspections and internal inspections
- Ensuring regulatory compliance with MHRA licences (e.g. Assembly, Specials, Vet Specials, Wholesale) and Home Office licence.
- Ensuring that there is a self inspection programme in place which is communicated to Operations to meet the requirements of EU GMP
- Ensuring sufficient QP resource to provide QP certification for commercial and clinical trial products.
- Ensuring appropriate investigation of discrepancies, errors, complaints, failures or adverse events requiring documented review and action (if necessary, interrupting processes causing material to be quarantined or placed on hold until matters are resolved).
- Managing, motivating, coaching and mentoring direct reports, to higher levels of management capability.
- Ensuring that the Quality department meets or improves on budget, cost, volume and efficiency targets (KPIs) in line with business objectives.

Person Profile:

- Scientific degree (ideally pharmacy, pharmaceutical sciences, chemistry or related).
- Eligible to be a Qualified Person in accordance with directive EC/2001/83.
- Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level.
- Good understanding of the pharmaceutical market, including the unlicensed medicines sector.
- Wide knowledge of products and processes used in the manufacture of unlicensed medicines.
- Strong leadership/team management skills and experience.
- Strategic thinker with the ability to influence at a senior level.

This is a great opportunity to join an award-winning company. If you feel that you have the relevant skills and experience required for this role, please send an updated CV to Jade Tetlow or call on 0207 7587311.

Keywords: Quality Assurance Manager, Manager, Head of Quality, Quality Assurance, QA, Internal Audit, External Audit, Quality Systems, Quality Management Systems, QMS, Compliance,API, Responsible Person, IMP, SpecialsTo find out more about Real please visit www.realstaffing.com

Projektdetails

  • Vertragsart:

    Permanent

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    Sonstiges

Real Staffing Group

  • Straße:

    Grosse Bockenheimer Strasse 50

  • Ort:

    60313 Frankfurt am Main, Deutschland

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