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.
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