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Job description:
If you have an eye for detail and want to help assure quality and facility qualifying and monitoring supply chain’s via audits in the animal health, pharmaceutical and similar regulated environments space, then this is the role for you! We have upcoming projects in Switzerland, Austria, and/or Germany and the European Union in 2024, 2025 and beyond!
We're looking for an auditor in Switzerland, Austria, and/or Germany to perform audits in these countries and potentially other EU countries.
The first opportunity of the year is a 1-day on-site audit August, Switzerland targeted for the Apr/May/Jun 2024 time period.
We're looking for a Sr. Quality Auditor with the following knowledge and experience:
•Language: Ability to conduct an English or German, to read English and German, and the ability to write a report in English. Knowledge of Swiss German would be nice but is not required.
•Technical Qualifications:
At least five years’ experience in quality role and/or as auditor
Experience as lead auditor and/or in a quality role where you have been responsible for ensuring animal drug manufacturers’ compliance to good manufacturing practices (GMPs) and pharmaceutical drug products
Experience as lead auditor and/or in a quality role where you have been responsible for ensuring animal food and medicated feed manufacturers’ compliance to good manufacturing practices (GMPs)
Experience as lead auditor and/or in a quality role where you have been responsible for ensuring warehousing and distribution site’s compliance to good distribution practices (GDPs)
Experience as lead auditor and/or in a quality role where you have been responsible for ensuring active pharmaceutical ingredient (API) manufacturers’ compliance to good manufacturing practices (GMPs), including ICH Q7
Preferred to have experience as lead auditor and/or in a quality role where you have been responsible for ensuring primary packaging production site’s and secondary packaging site’s compliance to good manufacturing practices (GMPs) requirements:
Preferred to have experience and/or with following regulations. The auditor should be willing to familiarize themselves with these regulations 1) Verordnung über die Produktion und das Inverkehrbringen von Futtermitteln (Futtermittel-Verordnung, FMV) vom 26. Oktober 2011 (Stand am 1. Januar 2024), SR 916.307 2) Verordnung des WBF über die Produktion und das Inverkehrbringen von Futtermitteln, Zusatzstoffen für die Tierernährung und Diätfuttermitteln (Futtermittelbuch-Verordnung, FMBV) vom 26. Oktober 2011 (Stand am 1. January 2024), SR 916.307.1 3) Ministry of Agriculture, Livestock and Food Supply (MAPA),
What you’ll do:
You will be performing quality audits and writing reports, either internally, or at suppliers to SQA’s clients. Each client has unique program needs to which you will be oriented as part of your on-boarding for each program. SQA will provide the audit tools and templates you'll need to conduct the audit effectively and seamlessly in accordance with SQA's and our client's requirements.
What to expect:
You will be part of a global quality auditing team responsible for assuring quality in the supply chains of our clients in life sciences, including animal health. Covering your local region, you will work closely with SQA’s operations center to coordinate, prepare, execute, and deliver supplier quality audits based on client audit schedules. You will work with SQA’s world-class production team to align your expert findings to the individual structure and guidelines of each client’s managed audit program.
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