Qualified Professional

1 Days Old

Job Description ***Qualified Person (QP) Batch Certification is mandatory***

Purpose of Role
To perform final QP Batch Certification to ensure all products released to market comply with the requirements of the Manufacturer's Licence, Marketing Authorisations, ANDAs, Technical Agreements, CE certification, and relevant EU, USA, or other regulatory requirements (e.g. Russia, Brazil, Canada).
Key Result Areas
Ensure cGMP principles and guidelines have been met during manufacturing, packaging and testing.
Verify all batch documentation meets regulatory authority requirements.
Review and certify batches according to business shipment schedules.
Ensure Product Licences (Marketing Authorisations), ANDAs, Manufacturer's Licence, Technical Agreements and CE certification requirements are met.
Ensure planned changes or deviations are supported by appropriate sampling, inspection, testing and checks.
Ensure planned or unplanned changes in manufacturing or quality control are notified per established reporting systems.
Ensure manufacturing and testing processes are validated and all necessary checks and tests completed.
Ensure appropriate audits, self-inspections and spot checks are carried out by experienced staff.
Areas of Impact Affecting the Job
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Location:
Runcorn
Job Type:
FullTime

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