Job Description
Roles & Responsibilities:- Lead end-to-end CSV activities (inventory assessment remediation disposition).
- Support business separation for large GxP systems.
- Define & implement risk-based validation strategies.
- Review & approve test plans, UAT scripts, validation documents.
- Ensure compliance with regulatory & quality standards.
- Provide guidance, escalation & leadership to validation teams.
- Collaborate with global & remote teams.
- Requirements:
- 7 10 years in CSV / Validation roles.
- Experience in Pharma / Biotech / Medical Devices industry.
- Proven experience in regulated environments (FDA/GxP).
- Strong expertise in CSV (Computer System Validation) in GxP environments.
- Experience in ERP, Data Migration & Cloud Migration (Divestiture/Separation).
- Hands-on in Acquisitions / Divestitures / Business Separation projects.
- Deep understanding of FDA regulations & GxP standards.
- Experience with Risk-based validation approach.
- Strong knowledge of validation documentation (VP, URS, IQ/OQ/PQ, TSR, SOPs).
- Experience in UAT, Traceability Matrix & QA methodologies.
- Ability to lead teams & manage multiple projects.
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Skills
Acceptance Testingunmatched
Biotech and Pharmaceuticalunmatched
Business Supportunmatched
Cloud Computingunmatched
Computer Systemsunmatched
Data Migrationunmatched
ERP (Enterprise Resource Planning)unmatched
FDA (Food and Drug Administration)unmatched
FDA Requirementsunmatched
GxPunmatched
Leadershipunmatched
Maintain Complianceunmatched
Medical Equipmentunmatched
Multitaskingunmatched
People Managementunmatched
Process Validationunmatched
Project/Program Managementunmatched
Quality Assurance Methodologyunmatched
Quality Metricsunmatched
Regulatory Complianceunmatched
Riskunmatched
Scripting (Scripting Languages)unmatched
Standard Operating Procedures (SOP)unmatched
System Validationunmatched
Team Lead/Managerunmatched
Test Plan/Scheduleunmatched
Traceabilityunmatched
Validation Documentationunmatched
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