Supplier Auditor - Remote based

Thermo Fisher
Swindon, Gloucestershire, United Kingdom, United Kingdom
Competitive salary
13 May 2021
11 Jun 2021
Job role
Job Title: Supplier Auditor - Remote Based
Job Req: 154935BR

When you're part of Thermo Fisher Scientific, you'll do challenging work, and be part of a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of $20 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

How will you make an impact?
As a member of the Global Supplier Quality organization, the Auditor will be responsible for performing external supplier audits, assessing supplier capabilities, assessing and mitigating supplier risk and maintaining corporate Supplier Quality standards.

The candidate will work closely with Global and site Quality, Global and Site Procurement, and Site Operations to develop an annual audit plan that ensures continued qualification of all external suppliers. The candidate will work with the other global auditors to assign and conduct the required annual supplier audits and will work with suppliers to identify and implement CAPAs that resolve findings from the audit. The candidate will display expertise in various standards and regulations such as cGMP, ISO, CFR 21, EudraLex, ICH Q7, etc...

What will you do?
  • Conduct external supplier audits as per ICH Q7, European GMP guide I & II, ISO 9000/22000, IPEC, CFR110/210.
  • Adherence to timelines regarding availability of audit reports and other critical documents.
  • In collaboration with the relevant sites, establish CAPAs that are agreeable to both requesting site and the Supplier. Verify the timely completion of CAPAs by means of routine contact with the supplier.
  • Collaborate with the site management teams in the evaluation and approval of suppliers.
  • Act as the key contact for the assigned responsible site, provide guidance and coordinate on the corporate supplier management level, ensure both global supplier quality and site's need are mutually achieved.
  • Collaborate with the sites in negotiation and manage the issuance of the Supplier Quality Agreements.

How will you get here?
  • A minimum of a Bachelor's Degree is required in Chemistry, Engineering, Microbiology, or Biology is preferred
  • A minimum of 3-5 years of relevant experience in a GMP environment, in any of the following industries: Pharmaceutical, Medical Device, OTC Drug, Cosmetic and/or Food and Dietary Supplements, is required.
  • Experience working with internal or external partners to drive compliance, CAPA completion to audit findings, and/or performance improvement is required.
  • Experience in CAPA management systems (i.e. TrackWise)
  • Experience in a matrix organization
  • Knowledge of cGMPs, Quality System standards and regulatory requirements such as 21 CFR, ICH Q7, EXCIPACT, IPEC, ISO 9001, etc...
  • Ability to evaluate suppliers to different quality systems standards.
  • Understanding both receiving site and supplier procedures and practices.
  • Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint).
  • Effective written, interpersonal, and presentation skills.
  • Ability to travel up to 50% of the time.

At Thermo Fisher Scientific, each one of our 75,000 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.

Apply today!

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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