Quality Assurance Officer

JR United Kingdom; South Kesteven; On-site; GBP 80,000 - 100,000; Full time

Job description

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 your career.

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.