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Senior Specialist - Quality

Job LocationMerthyr Tydfil
EducationNot Mentioned
SalarySalary negotiable
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent,full-timeB

Job Description

Senior Specialist - Quality Merthyr TydfilA forward thinking global pharmaceutical company, going through a period of vast growth, is expanding the QA department, based in Merthyr Tydfil.Purpose:To support high profile clients with projects through development phase into commercial supplyResponsibilities:

  • Review and approval of technical documents to support manufacture in line with client supplied regulatory approved documentation, ensuring compliance to GMP
  • Oversee Operational activities supporting the Manufacture, Packaging and Analysis of finished product
  • Perform Batch Review to support QP certification
  • Support Client and Regulatory Audits, specific to assigned projects
  • Provide Senior Quality oversight of strategic client projects
  • Main point of quality for strategic clients for all quality enquiries
  • Attend regular client calls to provide on hand support and advise
  • Support investigations into Deviations, Out of Specification results and Requests for Change, giving consideration to GMP conformance and compliance to Regulatory Fillings
Background:Educated to a Bachelors Degree level or higher in a Scientific fieldAnalytical Development backgroundMinimum of 3 years QA experience5 - 10 years total experienceDesirable:Trainee QPKeywords:QA, Quality Assurance, QMS, Quality Management System, QC, Quality Control, Development, Analytical, Science, GMP, Good Manufacturing Practice, Pharmaceutical

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