Compliance QA Associate.

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: November 2027

• 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