Senior Quality Manager - Tech Transfer

Description

• 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.

• 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

• 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