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.
Location/Division Specific Information
The Groningen site is a multi-product and multi-client biopharmaceutical site with development and manufacturing facilities for pharmaceutical products for clinical trials (phase 1, 2 and 3) and commercial production.
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?
- Travel 50% +
- Conduct external supplier audits
- Perform supplier capability assessments
- Provide oversight of the Corporate Supplier Management plan, Audit & Reevaluation schedule.
- Knowledge of applicable Quality Standards, related Regulatory requirements and best practices.
- Understanding both receiving site and supplier procedures and practices.
- Adherence to timelines regarding availability of audit reports and other critical documents.
- Act as the liaison between Suppliers in their region and the Patheon internal sites.
- Collaborate with site management and global/site Procurement teams
How will you get here?A minimum of a Bachelor’s Degree is required in Chemistry, Engineering, Microbiology, or Biology is preferred
- Equivalent combinations of education, training, and relevant work experience may be considered.
- A minimum of 5-10 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.
- 3 years minimum required 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
Knowledge, Skills, Abilities
- 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.
- 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
- 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.
At Thermo Fisher Scientific, each one of our 65,000 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! 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.