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The company

Our client is a professional organisation, based in Netherlands. .

Role description

In this role you will bring in depth knowledge of European legislation and will contribute to continuously improving our processes.

Responsibilities

Responsible for ensuring compliance with the Manufacturing Licence
Certify batches for sale or supply
Participate in and approves where appropriate Annual Product Quality Review, Relevant Standard Operating Procedures, Complaint Investigations, Deviations, Supplier Investigations, Quality Agreements, Quality Continuous Improvement Projects;
Attends and participates in Event Reviews, Quality Systems Review, Site and Group QP meetings, Regulatory Body GMP
Is the primary contact person for the inspectorate and regulatory authorities regarding GMP;
Provide QP Guidance to the site and training and development in GMP and related issues;
Travel to the relevant customer facility for face to face Quality discussions if required;
Contribute to operational and strategic initiatives;
Focus the entire organization on delivering value for customers, including patients, by understanding and meeting their needs;
Make timely decisions at the right level with the right data, and support and document them once made;
Adhere to the highest standards of trustworthy and ethical behaviour in all interactions
Conducting supplier audits

Requirements

Ensures compliance of the business to all relevant legislation;
Has excellent planning & organising skills, accuracy and attention to detail and an ability to create a positive impact and convey confidence and credibility to others;
Has the ability to produce results, prioritise their objectives and schedule work to make best use of time and resources with a sound understanding of the commercial implications of role;
Must be able to cope effectively with pressure and setbacks and maintain commitment;
Must undertake stakeholder management of multiple decision makers, corporate colleagues, cross-functional team by demonstrating the ability to maintain and strengthen trust relationships with people on all levels.
Evidence of Continuous Professional development desirable;
Minimum 5 years relevant experience in the pharmaceutical industry in particular of which 3-years are in a Qualified Person role;
Sound Experience of pharmaceutical production including sterile manufacture, primary and secondary packaging;
Fluency in English

Other information

Heb je interesse en wil je meer weten over deze functie, reageer dan door op solliciteer te klikken en contact op te nemen met Greg Silberstein


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SIRE Life Sciences®

Ref. number: 47701
Listed by: SIRE Life Sciences®
Listed on: 15-05-2019
Country: The Netherlands
Employment: Permanent
Expertise: 6 - 10 years
Location Type: On location
Education: PhD.
Language: Dutch
Sector: Pharmaceutical
Specialisation: Quality

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Contact

SIRE Life Sciences B.V.

Mondriaan Tower
Amstelplein 52, 25th floor
1096 BC Amsterdam
+31 (0) 20 658 9800

SIRE Life Sciences Belgium BVBA

Science 14 Atrium
14b, Rue de la Science
1040 Bruxelles
+32 (0) 2 588 1277

SIRE Life Sciences Deutschland GmbH

Fünf Höfe
Theatinerstraße 11
80333 München
+49 (0) 89 3803 8966

SIRE Life Sciences Maastricht

ROOOMS Maastricht
Boschstraat 21
6211 AS Maastricht


SIRE Staffing Solutions

Keizersgracht 420 C
1016 GC Amsterdam
+31 (0) 20 658 9804

SIRE Information Technology

Calypso Building
Kruisplein 480
3012 CC Rotterdam
+31 (0) 10 316 1066

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Groot Handelsgebouw
Stationsplein 45 4th Floor
3013 AK Rotterdam
+31 (0) 85 044 4610

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1096 BC Amsterdam
+31 (0) 85 044 4640

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Amstelplein 52, 25th floor
1096 BC Amsterdam
+31 (0) 85 044 4620

SIRE Staffing

Mondriaan Tower
Amstelplein 52, 25th floor
1096 BC Amsterdam
+31 (0) 85 044 4650

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