QA / QC Officer - Pharmaceutical Technical Support

Our Client is a very successful pharmaceutical company. They are now seeking a QA / QC Officer to join their Pharmaceutical Development team. This position is a full-time permanent role and will be based near Hitchin, Hertfordshire . Job Profile An opportunity has arisen for a Pharmaceutical Technical Support Coordinator, reporting to the Pharmaceutical Technical Support Manager The successful applicant will provide support for the Pharmaceutical Development and Support Department, a manufacturing site in Norfolk and contract manufacturers Occasional travel will be required between sites. Key Areas of Responsibility Coordination and generation of Product Quality Reviews in conjunction with other departments and contract manufacturers Assessment of raw material specifications, pharmacopeial monographs (EP, BP and USP), relevant ICH guidelines (including Q3C, Q3D & M7), EMA requirements (Extractables & Leachables (E&L) and nitrosamine impurities) and other technical or regulatory documentation as required Writing and reviewing documentation for starting materials, product manufacture, filling and packing processes in conjunction with Marketing Authorisations or Technical Files Supporting current Quality Management Systems (QMS) including validation, changes and NC-CAPA Supporting commercial manufacture during the production process including process validation, technical support and projects Chairing and participation of relevant meetings, including generation of minutes and coordinating required actions as required Qualifications / Experience BSc (or equivalent) in a relevant scientific based discipline Previous experience in QA or QC (or both) in the pharmaceutical industry Previous experience in pilot production, commercial manufacture or an analytical environment would be beneficial, ideally in the pharmaceutical industry Strong report writing skills are essential along with the ability to work on several projects simultaneously whilst working under pressure to meet required timelines Previous project management experience would be beneficial Excellent interpersonal skills In return our client is offering a competitive basic salary plus comprehensive benefits for the successful Candidate Please send your C.V to Lorraine Roger, Director at Atom Recruitment Ltd.