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Patheon
QA Auditor (m/f)
Linz - Austria
Posted December 22, 2017

Join us as We Transform How Pharmaceuticals are Made.

Patheon is looking for people who are passionate about making a difference in people’s lives. Patheon is in need of proven leaders to nurture talent, build effective teams and drive engagement in an environment where people are motivated to do their best for the company, its clients and their patients. To inspire collaboration and innovation.
Summary
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.
Key Requirements
Conduct external supplier audits


Perform supplier capability assessments

Provide oversight of the Corporate Supplier Management plan, Audit & Reevaluation schedule.

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 Operations as well as Global/Site Quality and Procurement teams
Qualifications

University’s Degree in Chemistry, Engineering, Microbiology or Biology preferred. Equivalent combinations of education, training, and relevant work experience may be considered

A minimum of 5 years of relevant experience in a GMP environment, in either Pharmaceutical Industry, Medical Device, OTC Drug, Cosmetic and/or Food and Dietary Supplements

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

Experience in CAPA management systems (i.e. TrackWise)

Experience in a matrix organization

Knowledge of applicable Quality Standards, related Regulatory requirements and best practices.

Understanding both receiving site and supplier procedures and practices.

German and English on full proficiency level is mandatory

Travel Readiness

Help Us Make a Healthier World.

Patheon provides development and manufacturing services for more than 800 pharmaceuticals, including nearly a fifth of the world’s top selling drugs. We’ve helped our clients earn more than twice as many U.S. FDA approvals than any other CDMO. Are you as committed as we are to exceeding expectations with high-quality solutions to complex problems? If so, we want to talk to you about making a healthier world... together. Join us at patheon.com
 
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