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Sc Ysiiea recruiting qualified individuals for UK partners We are a MHRA licensed Pharmaceutical Relabelling Company looking to recruit a Qualified Person for our Quality Team. You will ensure that products sold by the Company meet the required quality standards to ensure patient and company safety. As the Qualified Person (QP), you will be able to fulfil the requirements of Article 49 of 2001/83/EC in respect of a Qualified Person
Skills & Experience • Previous Quality Assurance experience • Up to date understanding of regulatory expectations • Registered Qualified Person under the permanent provisions • Able to act as a coach and mentor in support of staff development Main Responsibilities • Certification of batches whilst ensuring timely assignation of verdicts • Ensure that PL and MIA licence requirements have been met • Work closely with the Quality team to ensure batch documentation review and certification are carried out in a timely manner • Assist in non-conformance investigations • Implement better ways of working that are quality related and cost effective and demonstrate continuous improvements • Ensuring compliance with GMP. • To participate in the execution of the internal and external audit process according to the audit schedules. • To review and approve Quality Agreements and Product Quality Review. • To review and approve deviations and customer complaints, and their associated investigations and CAPAs. • To review and approve qualification/validation protocols and reports. • Assist in MHRA or other audits to required standards.
Nivel minim de educatie necesara Colegiu / studii postliceale