Trading Entity Compliance QA Associate
vor 2 Monaten
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 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
- 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 multi-functional and multi-cultural teams
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