Beschreibung
Adecco IT is currently looking for a Senior QA/Process Quality Manager on behalf of its client, a major global company in the Healthcare sector located in Basel.
Job Purpose:
Support QA e-Compliance Managers to ensure that all aspects of global and local Computerized Systems comply with GxP regulatory requirements and the related NV&D Quality Manual.
Major Accountabilities:
- Ensure the monitoring of quality of the work in accordance with the Quality Plan, Validation Plan and regulations in place (SOP) within the organization
- Ensures proper documentation cycle management (creation, naming, review, approval cycle)
- Ensures the right communication and information exchange between the different quality instances (E-Compliance, Information Governance Management)
- Works jointly with the Test Manager for all testing related activities
- Authors all Quality deliverables (Quality Plan, Validation Plan, Functional Risk Assessment, Quality Report, Validation Report)
- Contributes and supports to the establishment of qualitative Test documentation
- Reviews and approves all the project and system life cycle project deliverables
- Works closely with and reports to the Project Manager
- Provide QA and advice the team where applicable to ensure Quality procedures are correctly applying.
Expected experience:
- Excellent interpersonal and communication skills and the ability to work well within a team environment.
- Excellent knowledge and understanding of Pharmaceutical Industry (CSV cycle) - GAMP/21 CFR Part 11 Certified
- Knowledge of Trackwise is welcome in addition
- 5+ years of experience in a similar position,working with international teams, open and aware on different cultures
Miscellaneous:
- Graduate in Pharmacy, natural sciences or information technology or several years of equivalent experience in pharmaceutical or related industry is a big asset
- Strong written and oral communication skills in English, German is a plus
- START: immediately
- Duration: 8 months
- Workload: 100% in Basel