The Quality Systems Specialist will drive ongoing delivery of the QSS team's goals while providing support to the development and execution of the Horsham site training program and facilitating continuous improvement. These responsibilities are critical in maintaining the health of the FCS Horsham and Crawley sites' Quality Management System (QMS) and ensuring compliance with GxP requirements.
Responsibilities
* Support the execution of electronic QMS processes, including review and approval of investigations, CAPAs, Change Controls, action items, and effectiveness checks.
* Monitor and drive timely completion of site QMS activities.
* Generate datasets related to key performance indicators (KPIs) and trend analysis to allow for short and long‑term strategic planning.
* Facilitate and lead meetings related to QMS activities.
* Provide a key point of contact for resolving end‑user queries.
* Administrate the eQMS and contribute to global system‑enhancement initiatives.
* Manage the eQMS.
Site Training Program
* Develop and deliver Horsham and Crawley site training content and associated documentation.
* Maintain and manage training records within the Learning Management System (SuccessFactors), ensuring data accuracy, completeness, and audit readiness.
* Support functional area ownership of new and existing training programs.
Continuous Improvement & Collaboration
* Collaborate with global and cross‑functional teams to align local practices with global strategies and standards.
* Author related procedures, standards, and documentation in line with compliance requirements.
* Participate in site management review activities and improvement projects.
* Provide support during client and regulatory audits by preparing documentation and responding to information requests.
* Support broader QMS‑related activities such as risk assessments, gap analyses and new product introduction.
* Promote a positive quality culture through knowledge‑sharing and user engagement.
Qualifications and Competencies
* Demonstrate behaviors in line with the Thermo Fisher Core Competencies and 4i Values.
* Take ownership, accept responsibility for your actions and make sound decisions with solid communication skills.
* Demonstrate an adaptive and flexible work style effective across varied clients, senior‑level leaders, and front‑line team members.
* Ensure compliance with cGMP, Quality Systems, and training requirements are met in line with business need.
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