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Sr. Assoc, Comp Sys Val

Req # JR - 022079 Location Ahmedabad, Gujarat, India 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.

Reasonable Accommodations

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