QA Product Specialist

Quality Assurance Product Specialist at Kyowa Kirin International plc Galashiels Kyowa Kirin have an excellent opportunity for a Quality Assurance Product Specialist at our Head Office in Galashiels, Scottish Borders. Role To provide QA support for the manufacture of Kyowa Kirin's products in order to ensure that each product is manufactured and supplied to the marketplace in compliance with cGMP requirements, Marketing Authorisations, company operating policies and procedures and business requirements Key Responsibilities * Participate in the appropriate project management meetings in order to keep abreast of ongoing activities, identifying and addressing any gaps relating to product quality and GMP compliance. * Prepare and maintain Technical (Quality) Agreements with third party contractor manufacturing organisations (CMOs) so that roles and responsibilities between the contracted parties are clearly defined and implemented * Ensure that an appropriate level of product batch record reviews are carried out at the CMO facilities and within KKI, as necessary, prior to the release of product for sale and distribution * Regularly review non-conformances e.g. process deviations, out of specification/trend results etc at the CMO to ensure that resulting investigations have identified the root cause(s), that suitable reports have been written and that corrective and preventative actions (CAPAs) have been implemented within suitable time periods * Ensure that all changes to GMP documents, processes, equipment and facilities are effectively managed through the CMO and KKI change control processes in order to maintain GMP and regulatory compliance * To carry out a review and approval of validation protocols and reports during Technical Transfer and process change activities in order to ensure that manufacturing processes and analytical procedures at the CMOs operate in a validated state * Ensure that an appropriate response has been provided by the CMO following investigation into customer complaints and that corrective and/or preventative actions have been implemented, as necessary, at the CMO facilities * Ensure that Product Quality Reviews have been carried out and reported by the CMO(s) and that any trends have been identified and corrective and/or preventative actions implemented * Ensure that GMP stability programmes are established, implemented and regular reports issued by the CMO(s), that trends in data and confirmed out of specification results are investigated and reported, as necessary, to QA management in compliance with cGMP and regulatory requirements * For each product, maintain a Product Quality Profile, as registered with the regulatory authorities, and provide to the CMO's Qualified Person (QP) so that product can be manufactured, controlled and released in compliance with the Marketing Authorisation * Take responsibility for one or more of the Quality System(s) - (Documentation Control, Change Control, Customer Complaints, Auditing, Training, Invoice Processing etc), when required, ensuring that personnel are suitably trained, that processes are operating effectively and that the system is regularly reviewed and improved, as necessary * To review departmental standard operating procedures (SOPs) for content and compliance with the appropriate regulatory requirements * Participate in the internal audit (self inspection) programme so that any gaps and deviations identified in systems and procedures are addressed by the relevant department and corrective actions followed up within reasonable time scales * To carry out staff training, including refresher training, in GxP activities, as necessary, to ensure that staff are kept abreast of current GxP regulations * Provide regular reports of key performance indicators to QA management, as part of the Quality System, so that the appropriate resources can be allocated and corrective actions implemented, as necessary * Provide cover, as necessary, for other QA departmental activities in order to maintain a continuity of QA service * Participate in the review and recall of defective product, as necessary, in order to minimise patient risk Position Requirements * A Life Science degree or equivalent * A broad experience of working within the pharmaceutical industry of which several years will have been operating in a senior QA Management position at a manufacturing site. * Excellent working knowledge of international GxPs, especially in the interpretation of MHRA and FDA requirements, for the manufacture, control and distribution of commercial product and clinical trial materials * Sound knowledge of the principles of solid and semi-solid dosage manufacturing processes (tablets, capsules, gels, creams, ointments) * Sound knowledge of QC and Stability chemical analytical testing techniques for solids and semi solids * Familiar with the regulatory requirements for validation activities as applied to manufacturing and packaging processes, analytical methods, cl