David Sack
Senior IT Compliance Analyst
- Role
- Senior IT Compliance Analyst at G&M Health, LLC
- Location
- Highland Park, NJ, US
- LinkedIn followers
- 500 followers
Experience
Senior IT Compliance Analyst
Nov 2019 — Present · Somerset, NJ, US
Manage multi-validation project enco using a flexible approach, combining Waterfall and Agile methodologies, with a particular focus on Agile using tools like Jira to enhance efficiency and adaptability. Conduct comprehensive internal, external, and vendor audits to assess and enhance validation processes, identifying areas for improvement and compliance gaps.Spearheaded creation, review, and approval of critical validation deliverables, including Validation Plans, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Traceability Matrix, and summary reports.Developed and maintained master validation plans, serving as blueprint for validation activities across multiple projects.
Skills
- Gamp
- Capa
- Glp
- Quality Assurance
- Computer System Validation
- Sop
- Fda
- Quality System
- V&V
- Corrective and Preventive Action (Capa)
- Validation
- Lims
- Trackwise
- Gxp
- Aseptic Processing
- Gmp
- Change Control
- U.s. Title 21 Cfr Part 11 Regulation
- 21 Cfr Part 11
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