Senior Specialist, Digital & Data Quality
USA - Delaware - Wilmington (Biotech), United States
R
USD 104K-163K Senior-level Full Time
Tasks
- Approve qualification validation documentation
- Assess and remediate legacy computerized systems
- Conduct incident management and change control
- Develop training programs for computerized systems validation
- Ensure GMP compliance for computerized systems
- Evaluate and implement new computerized systems
- Manage operating level procedures and validated status
- Mentor junior team members
- Monitor system health and compliance metrics
- Perform periodic review and investigations
- Provide quality oversight across computerized system lifecycle
- Resolve regulatory non conformance
- Review and approve SDLC documentation
- Review audit and inspection findings
- Support backup, restore, and disaster recovery
Perks/Benefits
- N/A
Skills/Tech-stack
21 CFR | 21 CFR Part 11 | ALCOA | Business Continuity | CFR Part 11 | CGMP | Change Control | Computer system | Computer system validation | Data Integrity | Deviation Management | Disaster Recovery | Disaster Recovery Planning | GAMP | GMP | GxP | Incident Management | Part 11 | Periodic review | Quality Auditing | Recovery Planning | Regulatory Compliance | System validation
Education
Regions
Countries
States
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