Jim Gleeson is 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 Persons QA 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 schedules Ensuring the ongoing compliance of the manufacturing facility, including implementation of new GMP requirements Ongoing training, coaching and mentoring of staff in GMP and complianceYour 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 products Ability to establish and maintain effective working relationships and communication links within the manufacturing unit, affiliated organisations and other customers Ability to interpret complex data and present key findings Ability to conduct audits internal and externally Ability to act as a mentor in support of Quality staff development Salary:Competitive with an excellent benefits packageApply: It is essential that applicants hold entitlement to work in the UK. Please quote job reference 143532 in all correspondence.If this position isn't suitable but you are looking for a new role, or if you are interested in seeing what opportunities are out there, head over to our LinkedIn page (cka-group) and follow us to see our latest jobs and company news.
Job Title
Qualified Person