IT KeySource, Inc has openings for the position Validation Engineer with Master's degree in Health Informatics, Any Analytical Science or related to analyze validation data, prepare reports including preparation of standard operating procedures by adhering to FDA, cGMP standards.
Job Requirements:
- Develop and execute Validation plans (VP)
- Create Validation Protocols (IQ, OQ and PQ)
- Perform GxP assessment
- Develop Requirement Traceability Matrix (RTM)
- Prepare Summary Reports (Validation summary reports VSR)
- Develop Standard Operating Procedures (SOPs)
- Perform GAP Analysis
- Create Remediation Plan
- Maintenance of hybrid systems
- Manage close and open record systems in cleaning validation
Work location is Charlotte, NC with required to travel and work from various unanticipated client worksites throughout the USA.
Application Instructions:
Please mail resumes to: 11220 Elm Lane, Suite #204, Charlotte, NC-28277 (OR) e-mail: hrteam@itkeysource.com
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