Lead Validation Analyst ( Gxp,Gmp)

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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