Job Description

Key Roles and Responsibilities:-

Direct supervision, line management and workload planning for the Quality Assurance (QA) Operations team. Coordinate activities of a QA Operations team to ensure development, manufacture, testing and release of products is carried in a compliant manner and in adherence to the required manufacturing, testing and release schedule. Assure compliance of procedures according to internal guidelines and UK/EU/US/ICH and other region specific guidance. Provide QA oversight and input to all site activities including; audits, review and approval of deviations, change requests, specifications, Standard Operating Procedures, validation documentation, manufacturing and analytical Procedures. Ensure QA support for client quality related requests, project meetings and input to discussions on resolving any quality issues. Support trending of Quality KPI's and provision of metrics for Corporate Quality reports and Quality Management Review meetings. Ensure QA support for validation activities including approval of protocols and reports for analytical methods, manufacturing processes and cleaning. Highlight GxP areas of concern and ensure appropriate investigations and CAPA plans are developed. Lead quality related investigations, assist in the development and approval of effective CAPA in order to resolve product, audit and customer issues. Participate in the audits of suppliers, internal facilities and support functions as required. Support effective pre-audit preparation, management, and clos-out of client/MHRA/FDA and other regulatory body audits. Provide quality support in the introduction of new products and processes, liaising with process and analytical development, quality/regulatory, manufacturing, NPI, Engineering and Manufacturing teams as required to ensure that all GxP requirements are satisfied. Provide QA support to key site / business initiatives and projects, participating as required. Development and training of department and site personnel to ensure current GxP knowledge and competency in performing roles in a compliant and effective manner. Ensure QA review perform all required reviews and checks of manufacturing, laboratory and associated documentation prior to the relevant disposition of API products and assessment of conjugation products to site QP's for disposition. Immediately escalate any significant breach of quality or regulatory compliance to the QA Manager and Head of Quality. Keep current on GxP quality standards, guidelines and best practices. Ensure compliance by promoting understanding of the underlying concepts. Identify opportunities for improved methods of working to enhance GxP and Safety performance, efficiency and cost control. Ensure productive working relationships are maintained between QA and other site personnel and stakeholders. Actively contribute to the development and maintenance of a knowledge based, supportive and collaborative working environment within QA and in interactions in a wider cross-functional setting.

Key Competencies:-

Attention to detail Knowledge of GxP (GMP/GDP/GcLP/GCP) standards as applicable Knowledge of UK/EU/ICH/FDA guidelines Risk based decision making skills Excellent communication skills and patient customer/ customer focus * Ability to influence peers and senior managers