Quality Manager - Tech Transfer

England  ‐ Onsite
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Keywords

Description

You will manage the quality and compliance aspects of the Technical transfer of manufacturing and testing activities from their site to a number of Contract Manufacturing Operations (CMO).

Key Accountabilities:
  • Supports the quality aspects of the supplier evaluation process to approve the new Contract Manufacturing Operations.
  • Manages and monitors the execution of the actions needed to mitigate any risks as identified in the project risk assessment.
  • Ensure the Technical agreements are in place with the CMOs in advance of manufacturing commencing.
  • Coordinates completion of CAPAs following supplier audits.
  • Completes the Quality approval on Validation and Stability protocols and reports which will generate the critical information needed for regulatory submissions.
  • Supports the implementation of a Quality System between their site and the CMOs.
  • Ensures systems are in place to complete the batch document review on the initial batches made at the CMOs.
  • Provides guidance and quality support to the Technical Transfer Team.
  • Acts as the main Quality point of contact for the project.
  • Works closely with the regulatory team to ensure critical data is available for regulatory submissions.


Essential criteria
  • Hold science or engineering degree
  • Previous experience in an API manufacturing environment
  • Substantial previous experience in a QA management role
  • Project management experience
  • Strong leadership and drive
  • Excellent communication skills
  • Thorough knowledge of the legal requirements, rules and guidance covering the manufacture of Pharmaceuticals in Europe.


Desirable Criteria
  • Previous experience in a liquid or pharma manufacturing environment
  • Good IT skills
  • Previous line management experience
  • Eligible to act as a Qualified Person


This is a great opportunity to be a part of a multi national organisation with huge scope to progress in your career.

If you are interested in the position please send an updated CV to Jade Tetlow or call for further details I would be happy to discuss.

We also offer £200 for all referrals

To find out more about Real please visit www.realstaffing.com
Start date
07/2013
From
Real Staffing
Published at
11.05.2013
Project ID:
535026
Contract type
Freelance
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