Pharmaceutical Documentation / QA Support Coordinator
Full job description
Hudson Shribman
Salary: £21.6 per hour
Pharmaceutical Documentation / QA Support Coordinator c£Competitive +Benefits
South East AB/J4812
A chemist or pharmaceutical scientist with documentation / QA experience with a background in a pilot production, commercial manufacture or analytical environment is urgently required to provide documentation support for the Pharmaceutical Development Department, manufacturing area and contract manufacturers.
Key responsibilities
* 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.
* 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.
Qualifications
* A degree in pharmaceutical science or chemistry equiv subject
* Documentation / QA support experience
* Previous experience in pilot production, commercial manufacture or an analytical environment would be beneficial, ideally in the pharmaceutical industry.
* Strong commitment to HSE and quality values
They offer an attractive salary (dependent on experience), commensurate with qualifications and experience as well as associated benefits
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