QA Product Specialist - United Kingdom
Want to know company name or location? Company managed [?]
- Our company is a leading biopharmaceutical company 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, our company 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.
- 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
- Minimum life science degree essential
- Broad experience of working in Quality Assurance within the pharmaceutical industry essential
- Experience 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
- Excellent communication and interpersonal skills will be necessary in addition to strong analytical and problem solving skills