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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.


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


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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