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Job ID :
63364BR
Location :
United Kingdom - Swindon
:
Job Description

Purpose of the Role
Single person accountable for Quality Risk Management (QRM) across the site and will own/promote/define the systems listed as key responsibilities.

Responsible for providing professional expertise and for implementing and executing QRM on site level. Individual will proactively identify and implement company guidelines and standards for GMP Quality Risk Management Process, including but not limited to quality of products ,processes, facilities, utilities, equipment, analytical and test method

Key Responsibilities:

  • Implement and maintain a robust and compliant Quality Risk Management system
  • Implement risk management principles, methods, tools and documents according corporate standards and procedures
  • Establish and execute training requirements for site SME’s and employees in QRM principles and practices
  • Oversee and monitor timely facilitation and completion of risk activities
  • Manage data analysis and statistical tools used to support QRM activities
  • Manage, update and monitor the site Risk Register and site Risk Plan
  • Conduct periodic risk review
  • Communicate the outcome from quality risk management activities and periodic reviews
  • Review, approve and support any Investigation, Deviation and Change proposals with QRM impact
  • Act as QRM SME with regulators / clients (i.e. key player of audits and inspections)
  • Act as QRM SME for new product introduction and for applicable capital projects (i.e. new lines/processes)
  • Staying up to date with QRM best practice and sharing that knowledge ensuring understanding and compliance with ICH Q9, EU and US rules and regulations
  • Represent the site in cross-site and/or corporate Working Groups harmonising practices across sites in the network
  • Report status of and promote QRM within the Senior Leadership Team
  • Support and encourage a “Quality Culture” and company values
Qualification & Experience:
  • Science based degree e.g.. BSc or MSc
  • Minimum 5 years’ experience working in a pharmaceutical quality or operations function, preferably sterile manufacturing.
  • Specialist within Quality Risk Management with a thorough understanding and experience with implementing ICH Q9 principles, methods and tools
  • Familiar with the following Risk Management tools: FMEA, FMECA, HACCP, FTA
  • Working knowledge of EU/US GMP regulations and guidelines for UK as per the ‘Orange Guide.’
  • Demonstrated leadership skills



Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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