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Qualified Person / Qualified Analyst

priority vacature priority vacature



A temporary position for the period of four months at a global pharmaceutical company
(Haarlem, The Netherlands)

Het bedrijf / The company

Our client is a global pharmaceutical leader and the world’s largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Their employees are at the core of their success, with colleagues in over 80 countries, delivering the world’s largest medicine cabinet to 200 million people every day. They offer a uniquely diverse portfolio of products and solutions for patients and they have built a promising pipeline centered around their core therapeutic areas. They are continually developing patient-centric solutions and significantly growing both their generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how they improve health and enable people to live better, healthier lives.

De functie / The role

As Qualified Person you will handle compliance activities in Quality Center NL in alignment with the business unit, in order to ensure that commercial products are handled compliant and distributed to the Netherlands and other European countries by meeting GMP & GDP, regional, local standards and customer needs. This means that you have to ensure QP batch certification according to GMP Annex 16 for products for the Dutch market as well as European countries. Furthermore, you will have to administer, maintain and develop systems for change control, deviation and CAPA handling. As a Qualified Person you will maintain and monitor a list of approved suppliers, customers and providers. Furthermore, you have to ensure that the Quality Agreements are drawn up and that you will kept updated with all local suppliers, customers and third party service providers as required. The Qualified Person will manage the portfolio with respect to new introductions, site changes and technical transfers to be in compliance with EU GMP and the organisation standards. Furthermore, you make sure that relevant quality related documentation is archived as required. Also, as Qualified Person you have to ensure that local deployment of action plan is related to quality incidents.

Het profiel / Your profile

• Master´s Degree in Pharmacy, Medicines, Biology is required or an equivalent combination of education and experience to the functional role to register as a QP
• minimum of 5 year experience as a QP in a pharmaceutical company or importer/distributor
• knowledge of pharmaceutical industry as it relates to QP regulations and Quality Compliance
• in-depth understanding of cGMP & GxP's regulations
• experience with development and implementation of Quality Systems and application of risk assessment tools
• proficient computer skills in current software including MS Office
• result-driven, open minded, adaptability and stress tolerant, organized, team-player
• excellent skills in English, both oral and written

Het aanbod / The offer

• a challenging job within a global pharmaceutical company
• a leadership role in an international environment
• a temporary contract from September 2020 until December 2020

Reactie / Reaction

Interested? Please send your resume and motivational letter by e-mail, with reference to DT/20-075-DD, 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.

More vacancies? Click on the link: http://www.derksenderks.nl/vacatures

Solliciteer hier
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Your referral to www.fmfvacatures.nl is appreciated.



Derks & Derks Detachering
Derks & Derks Detachering

Geplaatst op FMF: 31 juli 2020

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