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Permanent

Qualified Person

Hatfield
money-bag 10000-500000 Annual
2981037185
Posted 3 days ago

CK Group are recruiting for a Qualified Person, to join a long-established global pharma company, to be based at their EU HQ in the Home Counties. The Role:You will support the Associate Director Quality Operations in the implementation and maintenance of Quality Assurance activities relating to product support used for the manufacture, packaging, testing, storage and distribution of marketed products. Responsibilities:To carry out the legal duties of a Qualified Person (QP) as specified under EC directive 2001/83/EC as amended and 2001/20/ECReview and disposition batches for marketed products in accordance with the UK Code of Practice for Qualified PersonsQA review and approval of master and executed batch records and associated documentsPreparation, review and approval of SOPs, review and approval of qualification/validation protocols and reportsParticipation in the execution of the internal and external audit process according to the audit schedulesEnsuring the ongoing compliance of the manufacturing facility, including implementation of new GMP requirementsOngoing training, coaching and mentoring of staff in GMP and compliance Your Background:Full QP qualificationExperience with oral solid dose or sterile productsExtensive knowledge and experience of Quality Assurance, Quality Systems, GMP guidelines and an understanding of the manufacture and packaging of pharmaceutical productsAbility to establish and maintain effective working relationships and communication links

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