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.
Responsibilities include:
- Develop and execute Validation plans (VP)
- Develop Validation Protocols (IQ, OQ and PQ)
- Perform GxP assessment
- Create Requirement Traceability Matrix (RTM)
- Prepare Summary Reports (Validation summary reports VSR)
- Develop Standard Operating Procedures (SOPs)
- Perform GAP Analysis
- Create Remediation Plan
- Maintain hybrid systems
- Manage close and open record systems in cleaning validation
Work location is Charlotte, NC with requirement 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 email [email protected]
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