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Manager Quality Assurance

 — Rheinfelden
12.03.Fach­verantwortung100%

Tillotts Pharma (www.tillotts.com) is a fast-growing international specialty pharma company.

Manager Quality Assurance

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. We are dedicated to the development, in/out-licensing and marketing of innovative pharmaceutical products in the field of gastroenterology. We successfully market our own products as well as in-licensed products in over 65 countries through our affiliates as well as a network of carefully chosen licensing- and marketing partners. We are engaged in close collaborations with pharmaceuticals research centres and universities.

 

  • Provide assurance that GxP regulated computerized systems are suitably implemented and managed in accordance with Tillotts requirements
  • Provide support, guidance and advice with regard to computerized system validation within GxP area, 21 CFR Part 11 and EU GMP Annex 11
  • Provide support, guidance and advice with regard to IT Infrastructure qualification to comply with GxP requirements
  • Keep track on new regulatory guidelines and implement them together with the QA Team at Tillotts
  • Determine regulations that are applicable to a computerized system and needs for validation
  • Responsible for QA related tasks for Serialisation/TES
  • Review and approval of computerized system validation documents
  • Act as a primary contact person in CSV projects
  • ERP Key User and Core Team Member for QA Corporate
  • Manage and maintain the revisions/compilations of POL and SOPs/Ops
  • Perform and coordinate external and internal audits
  • Review of batch documentation/perform shipment releases
  • Process owner for deviation management

 

  • Minimum bachelor’s degree in a life science-related discipline
  • At least 5 years’ experience in Computerized Systems Validation (CSV)
  • Excellent knowledge in and understanding of regulatory requirements such as GxP & 21 CFR Part 11 and GAMP5 guidelines, EU GMP Annex 11
  • 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%)

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

- Human Resources, Tillotts Pharma AG

Tillotts Pharma AG
Baslerstrasse 15
4310 Rheinfelden

Info

Info

12.03.2020
Fach­verantwortung, 100%
Kontakt
Tillotts Pharma AG
Baslerstrasse 15
4310 Rheinfelden

Firma

Grösse:300 Mitarbeitende
Branche:Chemie/ Pharma
Offene Stellen:7 Jobs
Standort:Baslerstrasse 15
4310 Rheinfelden
Website:http://www.tillotts.com
Links:
Salary

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