Inserat vom Mittwoch, 10. Oktober 2018

Manager QA

Tillotts Pharma AGRheinfelden
  • Rheinfelden
  • Klein- und Mittelunternehmen
  • Festanstellung, 100%
  • Mitarbeiter

Manager QA 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.

Manager QA

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.

 

  • Coordination of quality relevant relations with suppliers (CMO) and customers (deviations, complaints, OOS, changes, PQR)
  • Review and approval of Master Batch Documentation from CMO
  • Responsible for CMO process validation and review/approval of linked documentation
  • Represent QA in special projects
  • Perform yearly supplier assessment/ Prepare PQR
  • Shipment releases (bulk, Finished Product)
  • Plan, conduct and monitor self-inspections and external audits
  • Assist and coordinate HA inspections
  • Monitoring and Implementation of new regulatory guidelines
  • Ensure that quality agreements with partners are kept up to date
  • Manage and maintain the revisions/compilations of POL and SOP
  • Support continual improvement and compliancy of our quality systems

 

  • Minimum bachelor’s degree in a life science-related discipline
  • At least 3 years’ experience in the pharmaceutical industry in a similar function
  • Good knowledge in GMP process validation (Manufacturing of oral dosage form)
  • Experience as a Quality Auditor (CMO/Distributor/External laboratories)
  • Good understanding of FDA, EU and ICH regulatory requirements
  • Fluency in English and German (in written and spoken), French is a plus
  • Flexible and structured team player with the ability to work in a fast-paced, rapidly changing environment and a problem-solving approach
  • Willingness to travel (10%)

If you are interested in this challenging position, please send your job application to

recruitment@tillotts.com

Electronic Communication with Tillotts: E-mails and documents sent via the Internet are neither confidential nor secure and could possibly be viewed and modified by third parties. Tillotts shall not be liable for damages arising from messages sent to Tillotts via unsecured e-mail. If you like to secure your electronic communication with Tillotts kindly send a blank e-mail with the following reference: request for encryption.

- Human Resources , Tillotts Pharma AG

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

- Human Resources , Tillotts Pharma AG

Tillotts Pharma AG
Baslerstrasse 15
4310 Rheinfelden

15 Jobs — Rheinfelden

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