Senior Quality Systems Specialist

Recruiter
Baxter
Location
Thetford, UK
Salary
Competitive
Posted
08 Aug 2019
Closes
31 Aug 2019
Ref
1211843178
Contract Type
Permanent
Hours
Full Time
Senior Quality Systems Specialist - Compounding

Location: Flexible (Home or Office based) - Anywhere in the UK with occasional travel to sites such as Oxford, Thetford and Croydon.

Summary

Providing Quality Systems support to EMEA and Global Compounding organization to ensure that all sites maintain a compliant, efficient Quality Management System (QMS) in accordance with local regulatory requirements for Good Manufacturing Practice and Baxter Global QMS requirements.

Reporting to the Regional Director Quality Systems you will drive continuous improvement of the Quality Management System across EMEA and Global Compounding.

Support all aspects of the Global Compounding business strategy and objectives.

Duties and Responsibilities
  • Ensure effective implementation of the Quality Management System in Compounding Facilities, in compliance with Global and local Regulatory requirements, including: System administrator for EMEA & Global Compounding Quality documentation: SOP creation, TcU issuance, distribution
  • BAXU (internal) training course are updated.
  • SME for Training: Develop and deliver training for operational and quality personnel on Quality Systems related topics as required
  • System administrator and/or SME for Quality IT Systems/Tools including: Trackwise, CQI, EWF, NOVA, Tableau
  • Coordination of Global Quality Alerts and Compounding Escalation issues activities
  • Coordination (data collection & analysis) of Quality KPIs/Metrics, Review Boards and Management Reviews. Including: Dashboards, MOST, Tableau
  • Support CAPA, Change Control and Validation related activities/the projects impacting Quality Systems, including coordination and execution of QS-related assessments and tasks
  • Participate in Internal, Corporate Regulatory Inspections as required, including coordinating relevant follow-up
  • Drive and support improvement and standardization of the QMS, including coordination of continuous improvement activities

Skills & Qualifications Technical:
  • A pharmacy, microbiology or science graduate with at least 3 years' experience in pharmaceutical or medical device industry
  • Experience in implementing and maintaining quality systems in a regulated environment, including document control, change control, nonconformance management, validation
  • Experience in data collation and analysis

Soft Skills:
  • Excellent communication skills, include good level of English (written & spoken), other European languages advantageous • Critical thinking, results-oriented, pragmatic
  • Displays excellent teamwork and collaboration
  • Ability to operate remotely and within a matrix of colleagues, stakeholders, partners Desirable Skills (non-essential)
  • Experience of compounding, aseptic technique and understanding of classified cleanrooms
  • Experience in project management
  • Experience in developing and delivering training

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