Senior QA Associate
Catalent require a Senior QA Associateat our Swindon manufacturing facility where they will be acting as an integral part of the batch release team, working with, and providing wider support to the QPs to ensure efficient batch release.
As the successful candidate, you will perform final review of batch manufacturing records, and subsequent LIMS release of intermediate batches, ensuring manufacturing records are complete in preparation for QP release of the batch.
You will also act as the primary internal customer contact for all aspects of product release, liaising with both external and internal resources as required.
Role Description:·Review executed batch records and release intermediate batches in LIMS. ·Review completed batch documentation, liaising with Operations and / or QA Officers to resolve and clarify any points of issue.·Act as primary customer contact for all aspects of Product release, liaising with both external and internal resources as required. ·Perform transactional activities within relevant systems such as TrackWise and JD Edwards in support of final QP batch disposition.·Review and approve Master Batch Records ensuring alignment with agreed specifications and registered information.·Liaise with customers to determine the impact on the Marketing Authorisation of any deviation raised during the manufacturing or testing processes. ·Review and approve relevant customer.·Provisionally release batches of product to the customer pending full release by the Qualified Person.·Assist in conducting GMP training for the site for new employees.
Why Work for Us:Our Vision is to be the world’s most trusted, reliable and innovative drug development and deliverypartner by upholding the highest industry standards and exceeding customer expectations, while drivingstrong, sustained growth for the company. Competitive salary package + Bonus + Contributory PensionAbout Catalent:Catalyst + Talent. Our name combines these ideas. From drug and biologic development services, to delivery technologies to supply solutions, our highly skilled and dedicated global team of over 9,500 is passionate about improving health and wellness by combining their personal expertise and advanced technologies to advance science and supply products of the highest quality to customers and patients around the world. Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help develop some of the nearly 200 products we launch each year or help supply over 7,000 products for patients around the world. Catalent is an exciting and growing international company where our professionals work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market, for the benefit of patients globally. Our MISSION is to develop, manufacture and supply products that help people live better, healthier lives. OUR VALUES are at the foundation of everything we do: ·Patient First: We put patients at the centre of our work to ensure the safety, reliable supply and optimal performance of our products. ·Customer Dedication: We strive to exceed our customers’ expectations every day. ·People: We are committed to the growth, development and engagement of our people. ·Innovation: We develop and apply innovative solutions, superior technologies and continuously improved processes. ·Integrity: We demonstrate respect, accountability and honesty in every interaction. ·Excellence: We have a passion for excellence in everything we do.
Catalent. More products. Better treatments. Reliably supplied.™ Visit www.catalent.com/careers to explore career opportunities.
This job was originally posted as www.totaljobs.com/job/79163036