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Quality Assurance Specialist

2 months ago

Scotland, United Kingdom SRG Full time

Job Summary:

SRG is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality of our products and services.

Key Responsibilities:

  • Provide Quality Assurance Input: Collaborate with project teams to provide quality assurance input on 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 corrective and preventive actions (CAPA) to resolve production, audit, and customer issues.
  • Identify and Escalate Quality Concerns: Identify and escalate any identified good manufacturing practice (cGMP) areas of concern.
  • Participate in Validation Activities: Participate in validation activities, including approval of protocols and reports for analytical methods, manufacturing processes, analytical/production/packaging equipment, and cleaning procedures.
  • Participate in Supplier Audits: Participate in audits of suppliers, production, and support functions as required.
  • Prepare for Regulatory Audits: Be involved in the preparation for audits by regulatory bodies, such as the Medicines and Healthcare products Regulatory Agency (MHRA) and the US Food and Drug Administration (FDA).
  • Review Documentation: Review relevant documentation relating to incoming raw materials and perform disposition activities as required.
  • Review Manufacturing and Laboratory Documentation: Review 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:

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