Quality Assurance Manager

3 weeks ago


Horsham, West Sussex, United Kingdom Thermo Fisher Scientific Full time

Job Summary

The Quality Assurance Manager will provide leadership and oversight for all aspects of the validation and qualification process and activities across site. This includes Equipment, Facility, Utility, Cleaning, Computer system & shipper qualification activities.

The role will be responsible for assuring compliance with all relevant legislation and maintaining a best in class quality system ensuring that Quality Assurance is integral to the business strategy and 'fit for purpose' in delivering on Business Goals.

Key Responsibilities

  • To ensure that all routine requalification and new validation activities are carried out in accordance to the Validation Policy and Site Validation Master Plan and in line with documentation timelines.
  • To own procedures to be used on validation exercises and projects according to cGMP and Regulatory requirements and to manage the overall implementation of these exercises and projects including execution of protocols where required.
  • To track, trend and report on all validation/qualification and change control related metrics monthly and quarterly for management review.
  • To advise on validation requirements vital to maintain compliance with current GMP and regulatory requirements across site.
  • To collaborate closely, co-operate and train other departments to carry out validation process improvements and changes required to meet cGMP and regulatory requirements.
  • To act as Qualification and Validation SME in client audits and regulatory inspections.
  • To ensure the team provides quality management of the change control process and Maximo equipment maintenance system.
  • To act as Delegate for Senior QA Manager as required.
  • To undertake additional duties as directed and agreed with the Senior QA manager.

About Us

Thermo Fisher Scientific Inc. is a leading provider of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.



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