Supplier Auditor

Job Description

About Company:Thermo Fisher Scientific Inc. is the world leader in serving science, with revenues of $30 billion and approximately 80,000 employees globally. Our Mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. Through our premier brands Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services.Essential Duties and Responsibilities: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, etcRequirement:

• Travel 50% +
• 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.

Competency and Experience

• 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.
• With certain supplier auditing experience.
• 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
• Influencing & Decision-Making skills

Competencies:

• 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 work on multiple projects simultaneously.
• Ability to travel up to 50% of the time.
• Effective oral and written communication skills.
• Strong time management skills and the ability to work within a team as well as independently.

Physical Requirements:Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.Thermo Fisher Scientific, each one of our 80,000 extraordinary minds has a unique story to tell. Apply today http://jobs.thermofisher.com . 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. Apply Now,

Keyskills :
management skillsregulatory requirementssupplier managementsite operationsaudit reportsmanagement systemsgmpquality systemssupplier auditssupplier qualityquality systemsite management