Quality Systems & Compliance Specialist (Supplier Assurance)

Thermo Fisher
Swindon, United Kingdom
16 Sep 2020
17 Sep 2020
Job role
Responsible for the Supplier and Vendor assurance programme and associated activities
  • Act as SME for the Supplier and Vendor assurance programme
  • Maintain and keep the sites Approved Supplier List (ASL) up to date and in compliance with cGMP
  • Represent the Swindon site in working with the corporate supplier assurance function
  • Ensure all quality documents applicable to the Supplier and Vendor assurance programme are current and compliant with corporate standards and cGMP
  • Undertake supplier/vendor audits ensuring they are tracked, planned, executed and reported in a timely and compliant manner
  • Provide responses and CAPA plans to audit and/or inspections observations related to the Supplier and Vendor assurance programme
  • Provide QMR input and metrics on the Supplier and vendor assurance programme
  • Ensure KPI's and Supplier and Vendor scorecards are defined, tracked, reported and kept under control

GMP Compliance Support
  • Use GMP technical knowledge to write and prepare GMP documents relevant to the site
  • Use GMP technical knowledge to advise on GMP procedure simplification and training development
  • Train and support training in general GMP standards and specific GMP areas in your area of expertise
  • Ensure own KPI's, plans, targets and objectives are effectively monitored and achieved
  • Support audits and inspections as part of the Q Systems audit and inspections response team
  • Implementation of continuous improvement of GMP processes
  • Support projects within the department and cross functional on the site and/or within the network
  • Support and undertake other QA related tasks when required
  • Undertake and support Self-inspections and GEMBA walks
  • Stay up to date with corporate requirements, best practice and regulatory rules and regulations (within area of responsibility)
  • Act and behave as in accordance with the company's 4i values
  • Deputise for other QAO's in the department

  • Understand emergency procedures and comply with safe systems of work.
  • Ensure compliance with environment, health and safety rules, signage and instructions at all times.
  • Ensure prompt reporting and investigation of all accidents, near misses and breaches of rules.

  • Relevant science based degree; e.g. Chemistry, Biology, Pharmacy or equivalent
  • Working knowledge of the principles and guidelines for cGMP as set out in the 'Orange Guide'
  • Good knowledge of cGMP requirements for Supplier and vendor management desirable
  • Experienced auditor - not essential
  • Excellent writing & Communication skills

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