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Pharmaceutical Technical Coordinator in Hertfordshire
Pharmaceutical Technical Support Coordinator
Competitive salary plus benefits
- Coordination and generation of Product Quality Reviews in conjunction with other departments and contract manufacturers.
- Assessment of raw material specifications, pharmacopoeial 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.
Degree in a relevant scientific discipline with previous experience in pilot production, commercial manufacture or an analytical environment, ideally in the pharmaceutical industry.
Full knowledge of GMP and other pharmaceutical regulatory requirements (FDA, ICH etc).
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 along with excellent interpersonal skills.
Driving Licence as some travel between sites is required.