Trading Entity Compliance QA Associate

vor 1 Woche


Zürich, Zürich, Schweiz Swisslinx Vollzeit

On behalf of our client, an international healthcare company based in Switzerland, Swisslinx is looking for a Trading Entity Compliance QA Associate.

This is a contract for 5 months initially and role will be responsible for execution of daily activities associated with implementation and maintenance of the QMS and QA activities in relation to local Swiss Establishment License.


  • Start date: As soon as possible (latest in December)
  • Duration: 5 months
  • Workload: 100%
  • Location: Zurich
  • Hybrid work model (2 days per week on site)

Your mission:
Execution of all daily QMS activities such as but not limited to:

  • Work in a cross-functional team to ensure all quality master data under Trading Entity responsibility
  • Support mapping required GxP activities to be migrated as part of the integration activities of the Swiss Principal
  • Write, review and approve SOPs as required
  • Implementation, execution and administration of change controls, deviations and CAPAs
  • Ensure that accurare record, as required by the individual elements of the QMS, are kept and maintained in a secure manner
  • Support Trading Entity Compliance group to ensure related GxP activities which support company's global trading of products are compliant and efficient.

Activities include:

  • Ensuring that a quality management system is implemented and maintained
  • Focusing on the management of authorized activities and the accuracy of and quality of records
  • Ensuring that relevant customer complaints are dealt with effectively;
  • Ensuring approval of suppliers and customers;
  • Support in ensuring that selfinspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place ensuring that any additional requirements imposed on certain products by national law are adhered to.

Your profile:

  • Scientific Degree
  • Strong knowledge of global regulations relating to GDP, licensing, imports/exports and controlled drug / substance compliance
  • GDP, distribution, warehousing and transportation experience or proven equivalent experience
  • Good knowledge of SAP system and experience in data migration and/or integration of quality management system activities
  • Previous experience as RP preferred
  • GDP, distribution, warehousing and transportation experience or proven equivalent experience
  • Qualification to be an Industry Certified Responsible Person (RP) in Switzerland
  • Ability to make decisions on GxP/pharmaceutical activities to ensure regulatory compliance of company trading licenses and local regulatory requirements
  • Good Knowledge of HPRA healthcare legislation, GXP regulations and industry standards
  • Ability to work successfully in multifunctional and multicultural teams

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