Sr. Assoc, Comp Sys ValReq # JR - 022079 Location Ahmedabad, Gujarat, India Additional Locations 48 Job Category Quality Control Date posted 07/15/2020
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- To ensure that all the computer system validations activities are carried out in accordance with approved procedure and protocol.
- To Ensure all the validations / qualification activities are completed as per the predefined schedule / timeline.
- To provide training on computer system validation and regulatory expectation to all level of employees.
- To support life cycle processes such as change control and documentation Management
- To Review / approve Gap/ risk assessment plan, assessment checklist for GxP Computerised system based on GAMP 5 guideline.
- To review and approve all recommendation points of GAP / risk assessment with respect to EU Annex 11, Gamp5, 21 CFR part 11 and other regulations.
- To review and approve of all validation documents based on principle of ALCOA++ for validation docs.
- To Ensure that all appropriate quality procedures are in place to support computer system Validation process.
- To monitor compliance with regulations and established standards.
- To review and approve of all QMS documentation related to CSV activities.
- Actively participate with external agencies and ensure execution of validation activities
- To ensure that the facility / equipment / systems / utilities used are in validation state as per the internal procedures and in line with regulatory expectations.
- To ensure the computer system validation approach follows the requirements of the recent regulatory guidance and Global Quality Procedures.
- To be responsible for CSV team planner of validation activity.
- To review the summary of the validation activity and provide inputs for continued process verification.
To prepare / review the Validation and qualification protocols / reports.
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