QA Product Specialist
Quality Assurance Product Specialist Located in global head office in Galashiels, Scottish Borders Competitive salary Kyowa Kirin International plc. Is a leading biopharmaceutical company with headquarters in Japan whose substantial reinvestment into R&D is creating products at both early and late stage development. With a focus on core business areas of oncology, nephrology, and immunology/allergy, Kyowa Kirin leverages antibody-related leading-edge technologies, including its POTELLIGENT® Technology to discover and develop innovative new drugs aiming to become a global specialty pharmaceutical company which contributes to the health and well-being of people around the world. We are entering an exciting pre-launch phase with an array of development and in-licensed global products which will join an expanding, successful product portfolio, focusing on cancer supportive care, oncology and bone therapeutic areas. We can offer a talented, diligent quality Professional the opportunity to join us at this outstanding time; providing QA support for the manufacture of Kyowa Kirin International’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. This will include: Participation in project management meetings in order to keep abreast of ongoing activities, identifying and addressing any gaps relating to product quality and GMP compliance Prepare Technical Agreements and manage relationships with vendors and contract manufacturing organisation’s ensuring appropriate quality reviews and investigations are carried out Responsibility for one or more of the Quality System(s) - (Documentation Control, Change Control, Customer Complaints, Auditing, Training, Invoice Processing etc.) Manage QA aspects from change control to staff training along with following-up on customer complaints and review/approval of GMP documents About you: Graduate level life science degree essential, Post graduate qualification highly regarded Broad experience of working in Quality within the pharmaceutical industry essential Experience operating in a senior Quality position at a manufacturing site would be beneficial Exposure to reviewing and approving OOS investigations, deviations, change control and stability studies reports Knowledge of GxP audits Excellent communication and interpersonal skills will be necessary in addition to strong analytical and problem solving skills You will be rewarded with an excellent package, commensurate to the level of this role, and be based in Galashiels within the beautiful Scottish Borders; Edinburgh being only a 50 minute commute away, providing you with the opportunity to truly appreciate the great outdoors and city living. This role will also offer you the opportunity of global travel. Kyowa Kirin International is an equal opportunities employer.