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Computer System Validation Expert
1-4 years
Bangalore / Bengaluru
1 vacancy
Computer System Validation Expert
Saadhana Engineering Business Consulting Services
posted 6mon ago
Job Role Insights
Key skills for the job
Job Description
- Deliver CSV and roll-out activities within planned application changes and maintain
- relevant documentation based on the application
- Write and review performance qualification and user acceptance test scripts that
- adequately ensure business requirements are met for a given system
- Ensure close collaboration with appropriate system owners and key stakeholders in
- the business
- Ensure compliance of GxP application s operation and maintenance during its
- operational life
- Provide system audit support and ensure inspection readiness of applications
- Work with QA, Computer Systems Validation Committee and IT to document CAPAs
- and other quality items
- Review of database vendors qualification documentation, as applicable
- Work with vendors for change control management, incident management and
- issue resolutions
- Proactively identify and collate information required to assess compliance with
- processes and prioritize business process improvement needs.
- Review, assess and update procedural documents for overall compliance with
- current processes, as required
- Perform special projects, assignments, and administrative tasks per business needs
- Provide guidance and review or create varied support materials, presentations,
- and/or tools to support departments remit and strategies.
- Proactively collaborate with initiative leads and senior management to develop,
- optimize and improve CSV processes, training, and communications
- Mentor, coach and support team members
Employment Type: Full Time, Permanent
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