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 & Preventive Action Processes, Documentation, Quality Management Review (QMR), Communication and Training.
Qualifications
- 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.
- Experience in coordinating and supporting Document Control, Internal Audit, CAPA, Non‑conformance, and Complaints processes.
- Experience with Root Cause Analysis techniques such as GEMBA, 5 Whys, Cause and Effect.
- Working knowledge and hands‑on experience of software tools to lead Quality Systems processes such as TrackWise.
- Report and documentation writing skills.
- Risk management tools and methods.
- Excellent verbal and written communication skills.
Benefits
- Competitive total compensation package.
- Professional development opportunities.
- High importance placed on work life balance.
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.
Recruitment Fraud Notice
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