Key Roles/Responsibilities:- - QA primary point of contact (internal and external) for designated projects. - Collaborate with internal and external stakeholders to ensure quality of all product related activities. - Provide QA input to project activities including review and approval of change requests, specifications, Standard Operating Procedures, Manufacturing Procedures, Analytical Procedures and associated documentation. - Participate in quality related investigations, assist in the development, approval and implementation 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 and self-inspection of internal production and support functions as required. - Be involved in preparation for and successful completion of MHRA/FDA and other regulatory body audits. - Coordinate quality disposition activities associated with designated materials and products. - Verify manufacturing, laboratory and associated documentation prior to performing the relevant disposition of products. Where potential issues exist, these are to be highlighted to the QA manager. - Promote and work to ensure compliance with all relevant GMP/GxP requirements. - Support and lead as required, quality process improvements and quality management system improvements within the department and on site. - Escalate any identified GMP/GxP areas of concern to Quality Management and QP. Key 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