COMPETENCIES:-

• Attention to detail
• Good communication skills, both verbal and written
• Good organisation skills
• Ability to work effectively individually and as part of a team
• Ability to analyse data and information to make considered decisions
• The ability to identify root cause of problems to determine appropriate solutions
• Ability to prioritise workload to ensure timelines are met
• Ability to follow instruction accurately
• Ability to escalate issues as appropriate

• 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.