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Quality Manager

priority vacature priority vacature

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Introductie

Independent role / international environment / autonomous and responsible role

Het bedrijf / The company

Our client is the third largest producer of Inhaled Anesthetics and a global player in hospital generics. The organisation is motivated to deliver critical care solutions for patients and healthcare providers across the globe. They have a wide presence across Europe, the USA and more than 100 countries across the globe. Its rich product portfolio includes Inhalation Anesthetics as well as Intrathecal Baclofen therapy. This organisation has state-of-the-art manufacturing facilities in the US and India that have successfully cleared periodical inspections by different regulators. Their core strength lies in a highly qualified global workforce of more than 400 employees across 16 countries. They focus on further expanding its global footprint through new product additions in the critical care space. This vacancy is created due to relocation of the current Quality Manager.

De functie / The role

As Quality Manager you will be responsible for managing and maintaining the Pharmaceutical Quality System. This incorporates GMP, GDP and Quality Risk Management to support the manufacturing and importation authorisations or wholesale dealer licenses and controlled drug licenses as owned by The Netherlands sites. Furthermore, you will own and manage the required GMP and GDP documentation and QA processes as defined in the approved and implemented QMS documentation. In this position you will also act as a site Responsible Person.
Most importantly, you will fulfill an important role in developing, managing and optimising the quality system in collaboration with a team in the United Kingdom. This includes, the investigations into deviations, develop and report appropriate KPI"s, ensure the internal audits are performed on time and actively participate to all relevant activities required to ensure date integrity is continuously maintained and adequately controlled on site. Finally, you will ensure that QMS documentation is stored and archived, quality agreements with relevant supply chain parties or service providers are issued and maintained and ensure support in the new products or projects onboarding activities as requested by the business and within the quality organisation.


Het profiel / Your profile

o B.Sc. or M.Sc. degree in Life Sciences
o minimum of 5 years of experience in QA within pharmaceutical industry
o good technical knowledge of EU GMP/GDP, regulations and guidelines
o experienced in the management and maintenance of an EU regulatory approved QMS
o fluent in Dutch and English
o ability to work independently with limited supervision
o good team player, positive attitude and the ability to be flexible


Het aanbod / The offer

o challenging position within an international environment
o short lines of communication
o high degree of freedom and room for initiative
o good possibilities for personal/professional development
o ambitious and growing organisation


Reactie / Reaction

Interested? Please send your resume and motivational letter by e-mail, with reference to WS/19-052, to Tim van Loon: info@derksenderks.nl.
For further information, please call Tim van Loon 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

Uw referentie aan www.fmfvacatures.nl wordt gewaardeerd.
Your referral to www.fmfvacatures.nl is appreciated.


Gegevens

Werkgever:
Derks & Derks
Vacaturesteller:

Standplaats:
Voorschoten

Geplaatst op FMF: 26 juli 2019

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