Melissa H.
Vice President Operations San Diego at Validation Systems, Inc.
- Role
- Owner Vice President Operations San Diego at Validation Systems, Inc
- Location
- San Diego, CA, US
- LinkedIn followers
- 500 followers
Experience
Owner Vice President Operations San Diego
Jun 1994 — Present
Specializes in development and management of project schedules and overall project execution for validation activities for facilities, manufacturing and laboratory equipment, computer systems, and processes. Including project Validation Master Plans. Assembling a team of VSI validation personnel to write, execute, and develop final reports for project specific IQs, OQs, PQs and PVs and providing protocol and report reviews for validation work performed. Also, providing general project construction activities support including design review, inspections, specification and submittal reviews, and Construction Qualification.Development and implementation of Quality Systems, supporting SOPs and high level policies.
Education
State University of New York College at Geneseo
B.S.
Skills
- Software/Computer System Validation
- Biopharmaceuticals
- Lims
- Quality System
- Scheduling
- Laboratory/Analytical Equipment Qualifications
- Biotechnology
- Computer System Validation
- Capa
- Pharmaceutical Industry
- Sop
- Fda
- Process Scheduler
- Glp
- Change Control
- Project Management
- Facility and Utility System Validations
- Validation
- Gxp
- Aseptic Processing
- Process Validation
- Gmp
- Urs/Frs Writing
- Iso 13485
- Validation Master Plans
- Manufacturing Equipment Qualifications
- 21 Cfr Part 11
- Sop Writing
- Traceability Matrix
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