QA Process and Validation GMP

London  ‐ Onsite
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Keywords

Description

Primary Role
To provide QA and technical support as directed by the Associate Director, and in alignment with XXXX Global Pharmaceutical Technology and XXXX External Suppliers, in order to ensure XXXX's commercial products are manufactured and developed (and where applicable, tested and packed also) in accordance with their Registered Approvals (eg NDA, MA) and Site Authorisations and that the principles and guidelines of global GMPs are compiled at all times.

Responsibilities
-To develop and maintain globally, good working relationships with key XXXX contractors of Drug Product dosage forms (10%)
-Perform QA and cGMP preparation, review and approval of quality related protocols and reports at Drug Product contract manufacturers to include-
1.Validation/Revalidation activities
2.Technology transfers
3.New product introductions/launches
4.Process improvements/Global Pharm Tech support
5.Scale-up
-Represent GQA on multi function project teams and co-ordinate GQA activities associated with these projects, and provide QA and GMP advice to project teams.
-To ensure validation and technical activities are performed in compliance with cGMP and that quality issues are investigated and reported to Senior Management as appropriate
-Ensure master batch documents and executed batch documents relating to the validation activities above are reviewed and any queries resolved
-To develop and maintain good working relationships with other functions in GSC and SSP eg Global Pharmaceutical Technology, Global Materials Management and Global Regulatory Affairs
-To provide QA support for process improvement projects as required

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Start date
ASAP
Duration
11 months, with a view to extend.
(extension possible)
From
Generic Network
Published at
25.11.2011
Project ID:
273060
Contract type
Freelance
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