Senior Quality Manager - Tech Transfer

Job type:
Start date:
18 Months
Real Staffing
East Riding of Yorkshire
Published at:
flag_no United Kingdom
Project ID:

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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

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