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PQR Specialist



Introductie

A temporary assignment (9 months) at a large pharmaceutical company
(Boxmeer, The Netherlands)


Het bedrijf / The company

Our client is a world leader in the healthcare industry. Through their medicines, vaccines, biological therapies, and support services they offer health solutions for people and animals in more than 140 countries. They also demonstrate their commitment to an increasing access to healthcare through far-reaching programs that donate and deliver their products to the people who need them. The organisation has three main locations with approximately 4,500 employees. This position is located in Boxmeer. The location has approximately 45 employees who are responsible for marketing, sales, distribution and support of the products.

De functie / The role

As a PQR Specialist you will work within the Quality department. As part of the team, you will monitor, trend and assure the Product Quality process performance, manage the product quality systems (e.g. complaints, stability study management), identify product deviations/ trends, investigate deviations and escalate product issues. This involves managing the general stability protocols and OnGoing Stability year plan. You will also need to follow up regulatory commitments regarding stability testing and evaluate stability profiles and perform trend analysis. Besides this you will coordinate and document initial stability Out of Specifications investigations (including Trackwise) and gather data and write Product Quality Reports (PQR). Some of your other responsibilities include identifying product and/or process improvements, managing the product quality complaint system and escalating of significant product quality complaints. After a training period you are expected to work independently.

Het profiel / Your profile

o Bachelor level (Dutch: HBO)
o several years of experience working with pharmaceutical products/ processes and Quality
o experience with GMP
o knowledge and experience with Product Quality Reports (PQR)
o ability to manage assigned tasks within given timelines and available resources
o knowledge of internal and external compliance requirements and quality guidelines
o results oriented and eager to learn
o customer focused, process oriented and data driven
o as a person you work accurately and poses of a pro-active attitude
o good team player but able to work independently as well
o strong oral and written communication skills in English and Dutch


Het aanbod / The offer

o a challenging job within a large pharmaceutical company
o a temporary assignment till at least December 2019
o contract of Derks & Derks Secondment & Interim


Reactie / Reaction

Interested? Please send your resume and motivational letter by Email, with reference to DT/19-037 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 Secondment & Interim as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.

Apply directly
If this is not quite the position you are seeking, please check http://www.derksenderks.nl/vacatures for other interesting jobs!



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:
Derks & Derks
Standplaats:
Boxmeer

Geplaatst op FMF: 11 februari 2019

Branche: Farma & Biotech
Functie: QA / regulatory
Opleidingsniveau: HBO / BSc, WO/academisch / MSc, PhD
Werkervaring: 0-2 jaar, 2-5 jaar, 5-10 jaar, > 10 jaar