Computer System Validation Consultant
||Perform quality and compliance checks of activities during the project/operational phase of the computerized system. Train the support teams on defined SOPs, track open issues and risks and ensure they are addressed by respective teams.
|Key Result Areas
- Play the role of coordinator for Change / CAPA / ER
- Prepare and facilitate IT Change Review Board meetings
- Initiate / monitor and track to closure of changes and CAPAs through tools like SolTraq, ServiceNow, etc
- Understand SOPs, PCYC SLC
- Understand existing processes in application area
- Review and coordinate the draft protocols/test cases
- Review validation deliverables
- Support periodic reviews
- Manage and monitor Audit and CAPA management
- Align and report to IT Compliance Lead
- Co-ordinate with offshore team to share the tasks and meet deliverable timelines
- Minimum requirement is a Bachelor’s Degree in Computer Science, Sciences or a related education (e.g. life science, medicine, commercial).
- Minimum 4 years Professional experience in managing quality / compliance in the regulated environments in a Pharmaceutical/Life Sciences Organization.
- Expert knowledge of GAMP5, Quality Management, Computer Systems Validation (CSV) and change management in a GxP environment.
Senior Technical Recruiter
; Fax: 888-400-2698
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