CSV Manager QA in Rheinfelden bei Tillotts Pharma

CSV Manager QA (m/f) in Rheinfelden bei Tillotts Pharma

Tillotts Pharma

As our team at our HQ in Rheinfelden is growing, we are looking for a

CSV Manager QA (m/f)

Your tasks

ERP Key User and Core Team Member (incl. Master Data Management) for QA Department Rheinfelden
Responsible for QA related tasks in relation to data integrity and electronic records management.
Ensure Software and IT compliance in general (TP QA Corporate), among others: Excel spreadsheet validation, computerized system validation, supplier (re)qualification for computerized systems and services
Responsible for QA related tasks for IT Changes and for Serialisation/TES
Review and approval of computerized system validation in general
Represent QA in CSV-related projects
Supervision of QA relevant issues/processes and support with focus in GxP-related computerized systems, IT, ERP, and Serialisation/TES
Coordination of quality relevant relations with suppliers and customers (deviations, CAPA, changes)
Manage and maintain the revision/compilation of quality documents (e.g. SOPs)
Review of batch documentation / perform shipment release
Completion of internal and external audits

Who you are

Minimum bachelor’s degree in a life science-related discipline
At least 5 years’ experience in Computerized Systems Validation (CSV)
Excellent knowledge and understanding of regulatory requirements such as GMP (including 21 CFR Part 11 and EU GMP Guide Annex 11) and GAMP5 guidelines.
Good knowledge in QA Compliance
Fluency in English and German (in written and spoken)
Flexible and structured team player with the ability to work in a fast-paced, rapidly changing environment and a problem-solving approach
Ability to work under pressure and prioritize tasks
Willingness to travel (5%)

Who we are

Tillotts Pharma (www.tillotts.com) is a fast-growing international specialty pharma company located outside of Basel, employing over 300 employees in Switzerland and abroad. Our employees will be happy to give you reasons why they enjoy working for Tillotts, and why we are a Great Place to Work® Not yet convinced? Have a look at our fringe benefits or contact our HR team, who will gladly provide more information about Tillotts.