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Pharmaceutical Technical Support Coordinator

Dermal Laboratories Ltd - Gosmore Full time

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, our manufacturing site in Great Yarmouth and contract
manufacturers; occasional travel will be required between sites.

The role will include but not be limited to the following:

  • 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.

To apply for this position, you must as a minimum hold a degree (or equivalent) in a relevant scientific based discipline. Previous experience in pilot production, commercial manufacture or an analytical environment would be beneficial, ideally in the pharmaceutical industry.