On the Austrian site in Linz more than 700 members work on custom manufacturing of active ingredients for our customers in pharmaceutical industry.
As a member of the Global Supplier Quality organization, the Senior Auditor will be responsible for performing external supplier audits, assessing supplier capabilities, assessing & mitigating supplier risk & maintaining corporate Supplier Quality standards.
The candidate will work closely with Global & site Quality, Global & 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 & 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…
- 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
Experience and Requirements:
- 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 50%
- employment with an innovative, future-oriented organization.
- outstanding career and development prospects.
- company pension scheme.
- Exciting company culture which stands for integrity, intensity, involvement and innovation
- a minimum monthly gross salary of € 44.286,62 according to the collective labor agreement for chemical industry. A potential overpayment depends on qualification and experience.