Overview
Remote
Depends on Experience
Accepts corp to corp applications
Contract - W2
Contract - 12 Month(s)
Skills
Gxp
GMP
Validation
Job Details
Lead Validation Analyst ( Gxp/Gmp)
Remote
12+Months Contract
Mandatory Skills: GMP/GXP
Job Summary:
We are seeking an experienced Validation Lead to oversee and lead validation activities in compliance with GMP (Good Manufacturing Practice) and GxP (Good Clinical/ Laboratory Practice) regulations. The ideal candidate will have a strong background in managing validation processes for systems, equipment, and processes within regulated environments, ensuring compliance, quality, and safety standards are met.
Key Responsibilities:
- Lead and manage validation activities for systems, equipment, and processes to meet GMP/GxP standards.
- Develop and execute validation plans, protocols, and reports.
- Coordinate with cross-functional teams (QA, IT, Operations) to ensure validation deliverables are completed on time.
- Perform risk assessments and gap analysis to ensure compliance with regulatory requirements.
- Provide technical expertise in validation processes and troubleshooting issues.
- Ensure all validation documentation is accurate, up-to-date, and in compliance with regulatory guidelines.
- Support internal audits and inspections related to validation.
- Mentor and guide junior team members in validation activities.
Education: At least a bachelor s degree (or equivalent experience) in Computer Science, Software/Electronics Engineering, Information Systems, or a closely related field is required for the project
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