3 weeks ago

Senior Specialist - Quality

Merthyr Tydfil Competitive Permanent

Senior Specialist – Quality 

Merthyr Tydfil


A 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 supply

Responsibilities:

  • 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 field

Analytical Development background

Minimum of 3 years’ QA experience

5 - 10 years total experience


Desirable:

Trainee QP


Keywords:

QA, Quality Assurance, QMS, Quality Management System, QC, Quality Control, Development, Analytical, Science, GMP, Good Manufacturing Practice, Pharmaceutical

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