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Supplier Auditor

3 months ago

Swindon, Swindon, United Kingdom Thermo Fisher Full time

Job Summary

The Supplier Auditor is a key member of the global Supplier Quality organization within the Pharma Services Group at Thermo Fisher

By joining the global supplier management team, you will receive benefits of individual development, challenge career path for growth, ideal balance between life and work, and what more, an excellent team to work with

We, as global supplier auditors, are responsible for global supplier Management including supplier auditing, supplier qualification. We aim to be an outstanding supplier management team that provides a continuously improving, controlled, compliant and effective program through the recruitment and sustainment of competent talents.

What will you do

  • Perform assigned audits according to established supplier auditing program for all external suppliers within PSG division.
  • Responsible and lead the supplier audit process, ensure timely report issuance, observation and audit closure. Perform risk assessment for audit refusal and audit postpone.
  • Work with external suppliers for the CAPA implementation, risk assessment and drive continuous improvement and implementation of regulatory requirements to ensure supply chain sustainability.
  • Supervise the supplier qualification status for the responsible site, ensure supplier qualification criteria are met, maintain and update approved supplier list.
  • Establish new supplier questionnaire and supplier quality agreement, perform periodically review of assigned existing supplier questionnaire and supplier quality agreement.
  • Act as the liaison between GSQ and assigned PSG manufacturing sites, maintain routine interaction and provide support to for all supplier quality related issues.
  • Act as SME and key contact with cross functions (project, supply chain) for all supplier quality related issues.

How will you get here

Education

  • Bachelor's of Science Degree or related field, or a combination of education and experience.

Experience

  • Previous experience in pharmaceutical or medical device industry, or highly regulated industry with at least some experience in direct support of Supplier Quality Management.
  • Knowledge in regulations and standards such as cGMP, ICH Q7A, ISO, CFR 21, EudraLex, etc.
  • Quality auditor certification preferred.

Knowledge, Skills, Abilities

  • Position will require travel (approx. 50% of your time) and requires flexibility at times for urgent needs. This travel will be to our sites and supplier sites across the UK and Europe.
  • Proficient in the development and execution of quality management systems.
  • Project planning and understanding of Excel, Word, Access, and supplier quality management software (i.e. SAP, TrackWise, etc.).
  • Excellent social skills: ability to build and be a great partner with internal and external customers.
  • Strong communication level both written and verbal.
  • Ability to maintain a high level of accuracy and attention to detail.
  • Ability to work independently and possess problem solving ability.
  • Appreciates and respects diversity & Inclusion, Multi-cultures and values.

Benefits we offer

In addition to a competitive base salary, you'll be eligible for company annual bonus, contributory pension plan, private medical insurance, life assurance, annual reviews, Employee Assistance Programme, 25 days holiday + Bank Holidays, free on-site car parking as well as other optional flexible benefits such as holiday purchase plan that you can tailor to suit you

About us

At Thermo Fisher Scientific, each one of our 100,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

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.