Quality Assurance Specialist

4 days ago

Grangemouth, Falkirk, United Kingdom Piramal Pharma Solutions Full time

Job Summary

The Quality Assurance Specialist will assist the QA Officer in the review of procedures, completed batch paperwork including manufacturing and analytical documentation. As the QA representative for new campaigns, the incumbent will handle aspects including process instruction sheets, change control, deviation, validation, customer audits, raw material and final product disposition. The Quality Assurance Specialist is expected to identify and escalate cGMP issues that have the ability to affect batch quality.

Key Responsibilities

  • 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.
  • 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.
  • Act as the QA representative for the introduction of new products, being a key member of the multi-functional team including R&D, QC, and manufacturing, thus ensuring that all cGMP documents are appropriate and all cGMP requirements are satisfied.

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