Sr. Process and Systems Optimization Specialist

**Summarized Purpose**:
- **Providing R&D Quality support to Affiliate Medical teams**
**Essential Functions and Other Job Information**:
- **Procedural Support**
- Review, monitor and approval of controlled process documents for quality, compliance, and commitment gaps, in co-ordination with Sub Process Owners (SPOs) or Process Owners (POs)
- **Compliance Support**
- Review, assess, monitor and approve process deviations
- Lead investigation and assist in Root Cause Analysis of Quality Issues (QI) and CAPA
- Review and approve Quality Issues (QI)
- Assist the CAPA owner in performing Root Cause Investigations, review and approve CAPA actions
- Monitor CAPA to completion
- **Audits and Inspections**
- Pre-Inspection Support
- Inspection Readiness Training
- Mock Interview sessions
- Pre-Inspection Doc request and review
- During Inspection support
- Co-host/Host
- Inspection Doc Request support
- Control Room support
- Post-In...