Quality Systems & Compliance Specialist (Supplier Assurance)

Recruiter
Thermo Fisher
Location
Swindon, United Kingdom
Salary
Competitive
Posted
16 Sep 2020
Closes
17 Sep 2020
Ref
122812BR
Job role
Accountant
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


EH&S:
  • 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.


Qualifications/Experience:
  • 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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