Qualified Person - Global Pharmaceutical company
Contract: 6 months contract (likely to be extended or made permanent)
SRG are working with a global pharmaceutical company to help them find an Qualified Perosn to join their busy team.
The main purpose of the role is 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.
- To ensure the principles and guidelines of cGMP have been met during manufacturing, packaging and testing operations.
- To verify all batch related documentation is compliant with the requirements of the regulatory authorities.
- To review and certify batches in line with business shipment schedules.
- To ensure Product Licences (Marketing Authorisations), ANDAs, Manufacturer's Licence, Technical Agreements, CE Certification requirements have been met to ensure compliance.
- 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
- To ensure planned changes or deviations in manufacturing or quality control have been notified in accordance with well-defined reporting system
- To ensure that manufacturing and testing processes have been validated and all the necessary checks and tests have been performed.
- To ensure appropriate audits, self-inspections and spot checks are carried out by experienced staff
- Experience with QP batch certification is essential
- Registration as a Qualified Person
- Significant experience in a senior Quality role with experience as a Quality Leader in a modern manufacturing environment within the pharmaceutical industry desirable.
To apply click the link or send your CV to email@example.com
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