Compliance QA Associate
Vor 4 Tagen
For our client, an international company based in Zurich, we are looking for a Compliance QA Associate
General Information:
Workplace: Zurich (hybrid model)
Contract : Temporary
Start date : January 2025
End date: 31st December 2025
Workload: 100%
Objectives of this role:
This 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.
Support the establishment of procedures and processes
Ensure all requirements to maintain the Establishment License are met
Tasks and responsibilities:
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 accurate records, 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 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 self-inspections 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.
Meets qualifications to be an Industry Certified Responsible Person (RP) in Switzerland
German Language B2 certification at minimum
Previous experience as RP preferred
Good Knowledge of HPRA healthcare legislation, GXP regulations and industry standards
Ability to work successfully in multi-functional and multi-cultural teams
Demonstrate unquestionable integrity and professionalism
Customer and patient oriented mindset
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
Ability to make decisions on GxP/pharmaceutical activities to ensure regulatory compliance of trading licenses and local regulatory requirements
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