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Vacancy details
Vacancy description:
Job Code:
J562828
Job Title:
Quality Assurance Manager GMP
Job Category:
Regulatory And Drug Safety
Contract:
Permanent
Discipline:
QA
Country:
United Kingdom
Location:
Berkshire, Hampshire, Surrey
Min experience:
N/A
Annual salary:
Negotiable
Apply by:
05 Sep 2008
International Quality Assurance Manager
We have an excellent opportunity that has arisen with a TOP global pharmaceutical company working to provide QA support and ensure that products are manufactured in accordance with Marketing/Manufacturing Authorisations and GMP guidelines. This role will report in to the Director of QA and is offering a competitive salary and benefits package. This is a varied and dynamic position that will offer plenty of challenges, a great prospect for an experienced individual who is able to work independently.
Responsibilities:
To establish and maintain close working relationships with all contractors
To ensure that Technical Agreements are established, maintained, implemented and revised regularly
To ensure that all activities comply with local and regional QA and GMP requirements
To audit International Contractor/Supplier
To provide QA support for R&D projects as they move into the commercial environment to ensure GMP issues are addressed during the transfer of product and technologies
To carry out QA management responsibilities in order to support the International businesses.
To provide QA support to the European Affiliates and new business opportunities, to ensure that GMP aspects are covered and potential quality issues identified and reported to Senior Management
To review Product Quality Review reports received, then forward to the Quality Compliance group for analysis
To investigate any quality related complaints forwarded by the Quality Compliance group and provide a report in a timely fashion
To complete regular compliance checks of the Technical Dossiers to ensure contractors continue to be in compliance
Requirements:
University degree in Chemistry, Pharmacy, Biology or other related scientific discipline
Eligible to act as a QP as defined in Directive 2001/83/EC
Practical experience for at least 7 years in the Pharmaceutical industry in manufacturing / technical / QA or QC role(s)
Good working knowledge of EU GMPs and familiar with other International GMP standards e.g. FDA
Keywords - Quality Assurance Manager GMP Hampshire South East International
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