Our client is a leading Biopharmaceutical company whose substantial reinvestment into Research & Development is allowing them to create products at both early and late stage development. Primarily focussing on Oncology, Nephrology and Immunology/Allergy, our client leverages antibody-related leading-edge technologies including their POTELLIGENT® Technology to discover and develop innovative new drugs. Their focus always has and always will be the health and well-being of people around the world.They are currently entering into an exciting pre-launch phase with an array of development and in-licensed global products which will join an expanding and successful product portfolio, focusing on cancer supportive care, oncology and bone therapeutic areas.We are seeking a talented Quality Assurance professional who will be providing QA support for the manufacturing of our clients 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.Your role 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.Preparing Technical Agreements and managing 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).Managing QA aspects from change control to staff training along with following-up on customer complaints and review/approval of GMP documents.The ideal candidate will have:BSc (Hons) in Life Science or similar and 3 - 5 years Quality Assurance experience.Broad experience of working in QA within the pharmaceutical industry.Experience of operating in a senior QA position at a manufacturing site to include sound knowledge of the principles of solid and semi-solid dosage manufacturing processes.Proven experience reviewing and approving OOS investigations, deviations, change control and stability studies reports.Demonstrable knowledge of GxP audits.In return you will be rewarded with a competitive salary, KPI based bonus, 25 days holiday plus bank holidays, company pension, childcare vouchers, private healthcare and life assurance/income protection.
