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Job Details

Global Product Quality Manager

Company: Barrington James Europe
Location:
Reference: GLB-PDCT-QA
Closing Date: 08 Jul 18
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

Our Client, a renown R&D Pharmaceutical company is looking for a Global Product Quality Manager, several years of experience in manufacturing required and excellent knowledge of English.

Requirements:

Ensure regulatory CMC compliance of all supervised IMPs and medicinal products with national and international guidelines/regulations and with the relevant Clinical Trial Applications and Marketing Authorizations.

Issue and provide regulatory chemical-technical-pharmaceutical quality documentation by considering current and relevant guidelines to support obtainment and maintenance of national and international Clinical Trial Authorisations as well as Marketing Authorisations.

Responsible for the elaboration of the CMC regulatory strategy for EU and international markets, recommendations for elaborations of development standards and for the preparation of the chemical-technical-pharmaceutical quality documentation of IMPD/IND and medicinal product dossiers.

Providing critical assessment and strategic input, flagging risks, proposing mitigations as well as highlighting opportunities for the quality part of dossiers to maximize chances of success for approval.

Responsible for the availability, coordination and evaluation of relevant change control application to IMPs and medicinal products according to the established change management in order to maintain regulatory compliance.

 

Who are you? 

You have an university degree, preferably in Pharmacy and a profound knowledge of quality documentation for IMPS as well as medicinal products (CMC dossier).

You are experienced working in GMP environment

You possess an accommodative and flexible way of working is your strength and you strive for new solutions as well as driving realisation

Decision making is one of your capabilities also in difficult situations

You would like to apply your strong analytical and communication as well as stakeholder management skills

You are fluent in English (verbal & written) and can speak a second language fluently

Apply for this job: Global Product Quality Manager

Contact Information:

Address:  Head Office
Rowan House Smallfield Road Horley Surrey
RH6 9AU
England
Tel:  01293 776644
Fax:  01293 822333
Website:  Visit Our Web Site

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