Company: Skills Alliance
Location: Kingston upon Hull
Closing Date: 31 Jan 17
Salary (£): 30,000 - 40,000
Benefits: Bonus, benefits and potential relocation package
GMP QA Specialist, R&D – Speciality Pharma – East Riding of YorkshireSkills Alliance have partnered exclusively with this global speciality pharmaceutical company for the...
GMP QA Specialist, R&D – Speciality Pharma – East Riding of Yorkshire
Skills Alliance have partnered exclusively with this global speciality pharmaceutical company for the appointment of a GMP QA Specialist to maintain and develop new R&D quality systems for the delivery of IMP’s on brand-new facility currently under construction in East Riding of Yorkshire.
Responsible for maintenance and ongoing improvement of the new R&D QMS and ensuring all IMP’s for phase I-III clinical trials are manufactured to both internal and GMP guidelines. Working collaboratively with the CMC department and external CMO partners to review and improve manufacturing processes and maintain inspection readiness. Review of BMR’s in support of the QP and performing internal audits. Will also provide the unique opportunity to contribute to facility and equipment qualification and validation for the new site.
Prior experience of QA within pharmaceutical, BioTech or medical devices is essential along with a thorough understanding of GMP and GDP (GLP would be a distinct advantage). You will be dynamic with excellent interpersonal skills providing the ability to engage with professionals at every level of the organisation. Understanding of the activities of R&D, manufacturing and distribution of clinical trial material is highly desirable as is a background in chemistry.
In return you will gain unique experience contributing to the facility and equipment qualification for a brand new oral solid dose manufacturing facility as well as harmonising the global QMS. Potential to train internally as a QP within the near future.
Key Words: GMP | GDP | QA | Specialist | Officer | Associate | R&D | CMC | IMP | QMS | Quality Systems | Audit | BMR | QP | Manufacturing | Clinical Trial Material | Stability | Inspection Readiness | Quality Assurance | Yorkshire | UK | Pharmaceutical
If you would like to be considered for this opportunity, please click APPLY to send a copy of your CV. For further details and a full job description, please call Joshua Godden on +44 (0) 207 220 6224 or e-mail Joshua.Godden @SkillsAlliance.com. All queries are treated confidentially.
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