Senior Quality Manager - Tech Transfer

Job type:
on-site
Start date:
05/2013
Duration:
18 Months
From:
Real Staffing
Location:
East Riding of Yorkshire
Published at:
05/05/2013
Country:
flag_no United Kingdom
Project ID:
532010

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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 main site and the CMOs.
  • Ensures systems are in place at main site 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.


Qualifications/Knowledge & Skills: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


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

    If you feel you have skills suitable for this position please contact me as soon as possible either by email or telephone


To find out more about Real please visit www.realstaffing.com