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Manager Quality Assurance (m/f)

Tillotts Pharma AG
Rheinfelden

6T

For our highly dedicated Quality Assurance team in Rheinfelden we are looking for an experienced Manager Quality Assurance.

Manager Quality Assurance (m/f)

» Vacancies » Manager Quality Assurance (m/f)

  • 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
  • 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%)

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. More information can be found about us here. You can also learn more about Tillotts’ history here. 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.

Please note that we only accept direct applications (no recruitment companies)

- Human Resources, Tillotts Pharma AG