QA Compliance Specialist

This role will be responsible for execution of daily activities associated with implementation and maintenance of the QMS and QA activities in relation to the local Swiss Establishment License. Support the establishment of procedures and processes. Ensure all requirements to maintain the Establishment License are met.

Tasks & Responsibilities:
 

• Work in a cross-functional team to ensure all quality master data under RP 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 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
• 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 inter-vals 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

Requirements:
 

• 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
• Meets qualifications to be an Industry Certified Responsible Person (RP) in Switzerland
• Ability to collaborate and partner well at all levels, globally, regionally & cross-functionally
• Highly punctual, systematic, highly organized, & concise in communication
• Strong attention to details, ability to review & managing documentation
• Ability to make decisions on GxP/pharmaceutical activities to ensure regulatory compliance of our client’s trading licenses and local regulatory requirements
• Fluent in both German and English

Critical Skills & Competencies:
 

• Good Knowledge of Swiss 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

Sounds interesting? Apply now – we’re looking forward to receiving your applications!