Coordinate and manage as SMO Audit Coordinator the internal audit process in compliance with the internal and external requirements applicable to SMO.
Ensure completion of the annual internal audit program and the closure of the corrective and preventive actions related to audit findings.
As Lead Auditor, complete assigned internal audits for SMO according to the annual internal audit program and provide support for internal audits at other sites depending on demands.
Ensure deployment of global and local initiatives driven by site preparation to external inspections or visits from regulated bodies.
A Day in the Life
Internal audits:
- Lead the internal audit process at site level and represent SMO as part of CVG Internal Audit councils
- Establish the annual internal audit program and ensure its execution as per plan
- Prepare and complete audits according to the annual internal audit program
- Conduct meetings related to internal audits
- Prepare and gain approval for ABR record
- Document audit reports in Trackwise and participate to action plan definition
- Monitor the internal audit process according to defined performance indicators
- Remind action owners to close the actions according to plan
External audits/inspections:
- Prepare and implement site readiness programs for external inspections
- Lead site level activities required by MDT global initiatives related to regulations changes (MDSAP, MDR etc…)
- Support IKM related requests
- Coordinate with SMO department the Area Self Assessment initiative
Documentation System Management
- Support the Documentation Management Systems (DMS) used at SMO
- Perform Change Analysts activities as part of SMO Configuration Management group
Contribute and participate to a safety work environment, report any EHS risks and events (injuries, illness and accidents). Understand and enforce all Health and Safety policies, procedures and regulations
- 5 years of experience as Lead auditor in Medical Devices/pharma industry
- ETS/HES engineer or equivalent (Engineer degree diploma in technical/scientific fields)
- Internal auditor educational (lead auditor certification – IRCA ideally)
- Exposure to Compliance/Quality Systems Regulations (e.g. GMP’s, process/document controls, CAPA)
- Experience in internal/external audits coordination
- Fluent in French and English
- Extensive communication skills:
- to operate in multicultural environment and cross-geographies teams
- to interact and influence at various levels within the organization
- Rigorous, detail oriented, proactive, flexible, results oriented and motivated by achievement
- Autonomous, contribute to others’ success beyond own expertise and organization
- Decision making abilities