DETAILS:

International Quality Assurance Manager (QP / Pharma), £’s Negotiable, Job id: 38726227
Location: South East
Salary: Negotiable Bonus Share options
Company:Team 2000.
Job type: Permanent
Date posted: 05/06/2008 10:58


Description: International Quality Assurance Manager (QP / Pharma), £’s Negotiable, South EastMy client has a great new opportunity for an International Quality Assurance Manager to work from their base in the South East of England, you primary role would be to provide QA support, under the direction of the Director of IQA, to their International companies, to ensure that products are manufactured in accordance with their Marketing Authorisations (national or European), their Manufacturing Authorisations and that the principles and guidelines of current Good Manufacturing Practices, as laid down in Directive 2003/94/EC are complied with. Responsibilities in the role would be to establish and maintain close working relationships with all contractors the company works with; To ensure that Technical Agreements are established, maintained, implemented and revised regularly for all contractors; To ensure that all activities within IQA comply with local and regional QA and GMP requirements; To audit International Contractor/Supplier facilities and ensure they have effective Quality Systems in place so that they are in compliance with the principles of GMP, as laid down in the relevant EC Directives and guidelines.This may include facilities used for the manufacture of clinical trial materials; 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.This includes the following activities – Release of products for sale and distribution to the UK/ROI markets, after ensuring that the marketing and manufacturing authorisation requirements for the products have been met for the batch concerned, prior to release; Review and approval of master manufacturing and control documentation used at the contractors/suppliers in order to ensure they comply with requirements of the marketing authorisations and current GMP’s; Ensuring that appropriate audits, self inspections and spot checks are being carried out by experienced staff; Ensuring that the legal requirements regarding imported products have been fully met; Participate in product incident reviews to ensure that decisions taken are documented, and that corrective actions identified are implemented; Contact with local Regulatory Authorities e.g. MHRA (UK) and IMB (ROI) to discuss potential quality issues and recall activities.You will need a 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 10 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.They are essentially looking for “Rounded, broad, good manufacturing QA experience, from within Pharmaceutical industry. Experience of multiple presentations (ie many of solids, liquids, capsules, powders, non sterile.) Someone with technical strength combined with good communications / ability to resolve technical issues and who has dealt with multiple vendors (Contract Manufacturers and multiple outsourced suppliers ). Good knowledge of GMP in European context. Experience of FDA useful as well as other Global regulators. Ideally we would like a QP but this is not a prerequisite. I have lots more information about the company so if you are interested in this position and meet this brief criteria then contact me to discuss this opportunity further.


Contact: Mike Wilde
Reference: job/MW115
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