Description
Main responsibilities:* Leading role within the company Quality Assurance function, responsible for the continuous improvement of Quality related procedures and systems, in support of overall product integrity, ever-improving Quality Assurance and efficiency.* Management of the company change control system including the Quality and Regulatory review of proposed changes and post implementation review.* Overseeing the company deviation management system including a Quality and Regulatory review of unplanned deviations, instigating preventative and corrective actions and monitoring their effectiveness.* Assisting in the investigation of customer complaints, contributing to the formal response to the complaint, ensuring the instigation of effective preventative and corrective actions and tracking these to completion.* Compiling the company 'Annual Quality Incident Review' which trends and summarises deviations, complaints, corrective and preventative actions and other aspects of the company Quality Management System. * Review and approval of Annual Product Quality Reviews.* Reviewing Technical Agreements with Customers and Suppliers and where necessary discussing aspects of these agreements with the party concerned.* Overseeing the company equipment qualification, process and cleaning validation programs including the review and approval of validation protocols and reports in accordance with internal and customer requirements. Liaising with customers on areas of validation requirements with customers as required.* Be an active member of the company internal audit program.* Participate in site GMP audit by customers and regulatory authorities* Overseeing the company vendor assurance program, conducting audits of API manufacturing sites and printed component suppliers as required.* Continuous improvement of Quality related procedures and systems, in support of overall product integrity, ever-improving Quality Assurance and efficiency.* Maintain up to date knowledge of current expectations in EU Good Manufacturing Practice and Regulatory Compliance as relevant to the business.Salary is flexible, depending on the candidates experience. Please send an updated CV to Daljeet Pawar, or call for more information.For further information on this role please follow the the link attached Public Profile uk.linkedin.com/in/daljeetpawar/en