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SRG are working with a global name in the pharmaceutical industry to help them find a QA Officer.
If you have Quality Assurance (QA) experience from a GMP environment then this could be a great next step for you.
The company offer an excellent benefits package and flexible working.
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.
- 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.
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
Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.
