For our customer located in Zurich/Switzerland we are currently looking for a: Trading Entity Compliance QA Associate (m/f/d)
Tasks & Responsibilities
OBJECTIVES/PURPOSE
- 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
ACCOUNTABILITIES
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 our client’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 programm and necessary corrective measures are put in place
- ensuring that any additional requirements imposed on certain products by national law are adhered to.
Must Haves
- Scientific Degree
- Strong knowledge of global regulations relating to GDP, licensing, imports/exports and controlled drug / substance compliance.
- GDP, distribution, warehousing and transportation experienceor 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 experienceor proven equivalent experience
- Meets qualifications to be an Industry Certified Responsible Person (RP) in Switzerland
- 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
- Commitment to our client’s values and standards
Did we catch your interest?
The SimplyVision-Team is looking forward to receive your application (Word file is highly appreciated).
Kindly be informed that our customer is located in Switzerland. Therefore only applications from candidates within the EU or candidates holding Swiss work permission are required.