Overview
Hybrid
Depends on Experience
Contract - W2
Contract - Independent
Contract - 12 Month(s)
Skills
Auditing
Collaboration
Computerized System Validation
Documentation
GAMP
GxP
Management
Manufacturing
Quality Assurance
Regulatory Compliance
Risk Assessment
Job Details
Hi ,
Greetings !
We do have opening for our client,
Role : QA Validation Lead / CSV Lead
Location : Raritan, NJ
Duration : Long-term Contract
Job Description:
Responsible for overseeing Computer System Validation (CSV) and qualification activities in compliance with quality and regulatory standards. Lead validation strategy, risk assessments, and documentation for GxP systems and manufacturing processes. Ensure adherence to FDA, GAMP 5, and 21 CFR Part 11 requirements. Collaborate with cross-functional teams to maintain validation lifecycle and support audits and inspections.
Key Skills:
- Computer System Validation (CSV)
- Equipment & Process Qualification
- GxP / FDA / 21 CFR Part 11 compliance
- Risk Assessment & Change Control
- Validation Documentation & Audit Support
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