Apply for the Snr Quality Systems Associate role at Baxter International Inc. Location: Oxford, England, United Kingdom Your Role at Baxter The Senior QS Associate will lead and support initiatives to ensure continuous compliance of the UK Compounding business with cGMP, “Specials” manufacturing requirements, local procedural requirements, and Baxter Corporate policies. The role focuses on providing quality systems support across the UK compounding network. Responsibilities Ensure compliance with applicable GMP, GDP, MHRA, and other regulatory standards. Lead the development, implementation, and continuous improvement of the Quality Management System (QMS) in alignment with corporate and regulatory requirements. Review stability studies, product SmPCs, and relevant scientific literature to define compounded product stability data. Assess and document temperature excursion incidents within the Quality System. Own and lead Temperature Excursion Evaluation Tasks, ensuring timely and thorough investigation. Review and approve temperature excursion documentation and provide product disposition assessments. Support the management of stability records in the Pharmacy electronic systems Merlin and Mercury. Raise significant excursions through the nonconformance process. Ensure regulatory reporting of issues to local Regulatory Authorities as required. Lead and coordinate field actions and product recalls in accordance with Baxter procedure. Ensure effective communication and documentation throughout the recall process. Liaise with internal and external partners such as MoH, Baxter Compounding Units, Baxter Commercial and Medical Affairs teams, and Baxter Homecare. Collaborate with cross‑functional teams to assess impact and implement corrective actions. Lead and raise significant quality issues within the Global Compounding Organization for senior management awareness. Lead and support internal, corporate, and external/Regulatory audits. Support site audit readiness activities. Lead and support the annual internal audit program as required. Track and trend relevant unit audit findings. Additional duties: Introduction of New Drugs and Components, Change Control Process, Corrective
Snr Quality Systems Associate, in Stoke-on-Trent employer: Baxter International Inc.
Baxter International Inc. is an excellent employer that values its employees by fostering a collaborative and supportive work culture in the UK. With a strong emphasis on professional development, employees have access to growth opportunities and training programs that enhance their skills. The company also prioritises work-life balance and offers competitive benefits, making it a rewarding place for those looking to make a meaningful impact in the engineering and operations field.
