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QA/PV Manager

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Introductie

Pioneering role / international environment / autonomous and responsible role

Het bedrijf / The company

Our client is a leading player in the discovery of new molecules, both new chemical entity and new biological entity, with eight molecules in various stages of clinical development. The company has worked towards improving the lives of patients globally. In the pursuit of this mission, it has focused on the development of products that cater to the unmet medical needs. The company has primarily been structured into Drug Discovery and Development, Branded and Generic Formulations and Active Pharmaceutical Ingredients.
The company has a significant presence in branded generics markets across emerging economies including India. Its subsidiary has a fast growing and robust EU and US generics business and sales operations in over 95 countries. The subsidiary also markets APIs to regulated and semi-regulated countries. Our client employs more than 12,000 people and, with its sixteen manufacturing facilities in four countries, six R&D centers and front-end offices in US, EU, India, Brazil and other markets worldwide, they are well-placed on the road of growth.


De functie / The role

As QA/PV Manager you will be responsible for ensuring compliance to EU GDP, Quality Assurance requirements and pharmacovigilance regulations in The Netherlands. You will act as the key interface between the regional quality and pharmacovigilance functions and the local business, ensuring appropriate communication within the local business. In this position you will act as LPVRP and RP.
Most importantly, you will fulfill an important role in developing, managing and optimizing the local quality system as part of the implementation for the European QMS. This includes, but is not limited to, monitoring local databases, managing GxP related tasks, performing self-inspections and preparing for audits and inspections. You will be responsible for reviewing batch records, reviewing of temperature and humidity data logged during transportation and actioning on any deviations. You will communicate with Supply Chain, Manufacturing, Warehouses, Packaging sites and customers/patients to follow-up on and obtain/supply requested information. In cooperation with the Global PV and EU QPPV, you will provide regulatory authorities with any information relevant to the benefit/risk evaluation of medicinal products licensed in The Netherlands. Finally, you will maintain an efficient pharmacovigilance system in compliance with local regulations.



Het profiel / Your profile

o B.Sc. or M.Sc. degree in Life Sciences
o minimum of 3 years of experience in QA (within pharmaceutical or medical device industry)
o experience with Pharmacovigilance is strongly preferred
o experience with GDP and warehousing/customer service
o basic knowledge of pharmaceutical wholesale or manufacturing: GMP knowledge desired
o conscientious, responsible, ownership and analytical
o ability to build strong business and personal relationships
o fluent in Dutch and English


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 pleasant working atmosphere with low staff turnover


Reactie / Reaction

Interested? Please send your resume and motivational letter by e-mail, with reference to WS/18-064-FMF, to Vera Hudepohl: info@derksenderks.nl.
For further information, please call Vera Hudepohl 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

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


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Gegevens

Werkgever:
Anoniem
Vacaturesteller:
Derks & Derks
Standplaats:
Amersfoort

Geplaatst op FMF: 12 november 2018

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