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Quality Assurance Officer

2 months ago

scotland, United Kingdom SRG Full time

SRG are working on several opportunities for QA Officers.


If you have Quality Assurance (QA) experience from a GMP environment then we could have a great next step for you.


The Role:

  • Provide QA input to project activities including review and approval of change requests, specifications, Standard Operating Procedures, Manufacturing Procedures and Analytical Procedures.
  • Participate in quality related investigations, assist in the development and approval of effective CAPA in order to resolve production, audit and customer issues.
  • Identify and escalate any identified cGMP areas of concern.
  • Participate in validation activities including approval of protocols and reports for analytical methods, manufacturing processes, analytical / production / packaging equipment and cleaning procedures
  • Participate in the audits of suppliers, production and support functions as required.
  • Be involved in the preparation for MHRA/FDA and other regulatory body audits.
  • Review the relevant documentation relating to incoming raw materials and perform the disposition activities as required.
  • Reviewing manufacturing, laboratory and associated documentation prior to performing the relevant disposition of final products. Where potential issues exist, these are to be highlighted to the QA manager.


Requirements:

  • Degree in a relevant scientific, engineering or business discipline and/or relevant industry experience
  • Several years’ experience within Quality Assurance working to GMP guidelines
  • Experience of working within a Quality Management System e.g. completing or reviewing QMS documentation (SOPs/Deviations /Investigations /CAPA)
  • Experience of preparing and assisting in external audits with regulatory bodies such as FDA and MHRA
  • Organised and attention to detail
  • Strong communication skills across all levels