Job Description
PE Global are currently recruiting for a Qualified Person for a 12 month contract role with a leading multinational Pharma client based in Runcorn.
To perform final QP Batch Certification to ensure that all products released to market comply with the requirements of the Manufacturer's Licence, Marketing Authorisations, ANDAs, Technical Agreements, CE certification, in accordance with EU, USA, or other requirements e.g. Russia, Brazil, Canada.
Job Responsibilities
1. To ensure the principles and guidelines of cGMP have been met during manufacturing, packaging and testing operations.
2. To verify all batch related documentation is compliant with the requirements of the regulatory authorities.
3. To review and certify batches in line with business shipment schedules.
4. To ensure Product Licences (Marketing Authorisations), ANDAs, Manufacturer's Licence, Technical Agreements, CE Certification requirements have been met to ensure compliance.
5. To ensure planned changes or deviations are supported by appropriate sampling, inspection, testing and check to ensure compliance with the requirements of the regulatory authorities.
6. To ensure planned changes or deviations in manufacturing or quality control have been notified in accordance with well-defined reporting system.
7. To ensure that manufacturing and testing processes...