Overview
The Senior QS Associate will be responsible for leading and supporting initiatives to ensure the continuous compliance of the UK Compounding business to cGMP and "Specials" manufacturing requirements, local procedural requirements, and Baxter Corporate policies. This role focuses on providing quality systems support across the UK compounding network. Reports to the UK Compounding Quality System Manager.
Responsibilities
* Ensure compliance with applicable GMP, GDP, MHRA, and other relevant regulatory standards.
* Lead the development, implementation, and continuous improvement of the Quality Management System (QMS) in alignment with corporate and regulatory requirements.
* Stability and Temperature Excursion Management: 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; 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.
* Field Actions and Recalls: lead and coordinate field actions and product recalls; ensure effective communication and documentation; liaise with internal and external partners; collaborate with cross-functional teams to assess impact and implement corrective actions; lead and raise significant quality issues within the Global Compounding Organization.
* Audit Management: lead and support internal, corporate and external/regulatory audits; support site's audit readiness activities; lead and support in the annual internal audit program; track and trend relevant unit audit findings.
* Other duties: introduction of new drugs and components; change control process; corrective & preventive action; QA documentation; participation in Quality Management Review (QMR).
Qualifications
* Detail oriented; continuous learner; courageous; collaborative; critical thinker; influential; English minimum equivalent to RQF Grade 2, EQF Grade 3 or SCQF Grade 5.
* At least 2 years' experience in the pharmaceutical or medical device industry.
* Proven knowledge of Quality System processes.
* Bachelor's degree or higher in Pharmaceutical, Biotechnology, Chemistry or Microbiology.
* Minimum of 2 years' experience in quality team facilitation, project management, process improvement, or quality data analysis role.
* Experience coordinating and supporting Document Control, Internal Audit, CAPA, Non-conformance, and Complaints processes.
* Experience solving problems using Root Cause Analysis techniques (GEMBA, 5 Whys, Cause and Effect).
* Working knowledge and hands-on experience with software tools to lead Quality Systems processes (e.g., TrackWise).
* Report and documentation writing skills.
* Risk management tools and methods; excellent verbal and written communication skills.
Benefits
* Support for Parents
* Continuing Education/ Professional Development
* Employee Health & Well-Being Benefits
* Paid Time Off
* 2 Days a Year to Volunteer
* Competitive total compensation package
* Professional development opportunities
* High importance placed on work-life balance
* Commitment to growing and developing an inclusive and diverse workforce
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