Main Responsibilities:
1. Planning, managing and documenting customer audits
2. Answering customer requests for audit dates
3. Planning audits together with the project teams, based on the customers’ agendas
4. Organising the required infrastructure (meeting rooms etc.)
5. Accompanying the customer throughout the audit (plant tours, documentation review etc.)
6. Presenting Quality systems to the customer
7. Coordinating with the project teams to ensure that all SMEs and documents requested by the customer are available in a timely manner
8. Documenting the audits in TrackWise
9. Coordinating the responses to audit observations with the project team and ensuring that the customer receives the responses within the given timelines
Qualifications and Experience:
10. Relevant working/residency permit or Swiss/EU-Citizenship required
11. English is a MUST & German would help to interact with people on the site.
12. Understanding of the applicable cGMP regulations
13. General knowledge of manufacturing processes and analytical methods
14. Competent level of general IT skill is required
15. Auditing experience
16. Ability to align cross functional stakeholders
17. Understanding of customers' needs and requirements
18. Considering time sensitivity of requests to ensure customer satisfaction
19. Providing exceptional customer service by developing excellent working relationships with both external and internal customers
20. Must interpret and maintain proficiency in regulations, standards, guidelines and trends in cGMP