Job Description
* QA CMO Manager, 12-month Contract (MAT Cover)
* Addlestone, Surrey – 1x a quarter on site
* £500 per day – Inside IR35
Cpl Life Sciences is partnering with a growing pharmaceutical company that is looking for a QA CMO Manager on a 12-month basis.
The purpose of the assignment is to maintain CMO oversight/management and associated activities during the maternity leave of the permanent CMO manager.
CMO QA Oversight:
* Oversees the cGMP activities and processes for commercial drug substances, intermediates, and in-process and finished drug products manufactured by CMOs, supported by the line management.
* Provides QA oversight for technology transfers of commercial products to and between CMOs.
* Provide QA support for regulatory agency inspections at CMOs as necessary.
* Participate in CMO Business Review Meetings.
* Facilitates the resolution of all deviations, non-conformances and other batch related quality issues with the CMO to ensure product compliance.
* Employs a Risk Management approach to evaluate Quality issues to ensure that drug substances, intermediates, and in-process and finished drug products manufactured by CMOs conform to all regulatory and business product specifications.
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