Computer System Validation

9 hours ago

Ahmedabad, Gujarat, India Webosphere Full time ₹ 1,04,000 - ₹ 1,30,878 per year

Computer System Validation Engineer

Job Overview

We are looking for an innovative and experienced Computer System Validation (CSV) Engineer to join our team. The CSV Engineer will be joining a quality team that is validating the quality of a new software/system. You will be responsible for oversight of all GxP regulated computerized systems at all applicable points of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation (CSV) and Lifecycle procedures with Data Integrity requirements.

Experience

1-2 Years

Responsibilities and Duties

  • Preparation and review of Validation deliverables such as URS, GxP, Impact Assessment Checklist, VP, Specification documents (SDS, FRS, TS, CS), FRA, IQ Protocol & Scripts, OQ Protocol & Scripts, PQ Protocol & Scripts, DM (Data Migration) Protocol & Scripts, RTM, VSR, 21 CFR PART 11 & EU ANNEX 11 Compliance Checklist as per Webosphere CSV SOP.
  • Execution/Support in the execution of IQ, OQ, PQ, and DM test scripts on the internal as well client side.
  • Basic knowledge of industry standards related to computerized systems and Electronic Records/Electronic Signatures; 21 CFR Part 11, EU Annex 11, GAMP5.
  • Coordinate with Client to carry out Validation activity of Computerized Systems and Software.
  • Responsible for achieving & maintaining the validated status of in-scope computerized systems
  • Provide guidance on CSV validation issues and discrepancies
  • Support investigation of CSV defects and quality records (deviation, CAPAs).
  • Ensuring systems are fully implemented and integrated with other quality management systems, site and global functions.
  • Coordinating with teammates in achieving assigned tasks.
  • Issue/bug tracking, and software incident management.
  • Develop and execute test plans to ensure that all objectives are met.

  • Implement and monitor test scripts to assess functionality, reliability, performance, and

  • Coordinate and support to Quality Manager.

  • Ensure that user expectations are met during the testing process

  • Documentation adherence to internal/Client SOP and compliance.
  • Managing department functional process as specified in standard operation procedure & suggest changes if required.

Qualifications

  • Past experience writing, reviewing and executing computer validation documentation (URS, GxP, VP, Specification documents, FRA, IQ, OQ, PQ, RTM, VSR, 21 CFR PART 11 & EU ANNEX 11 Compliance Checklist)
  • Excellent written and verbal communication skills.
  • Proficiency with MS Office tools
  • Documentation management
  • Ability to work as a team player in a consulting environment
  • Knowledge of Computer System Validation.
  • Critical thinker and creative mindset – and the ability to approach a problem creatively.
  • A meticulous approach to work.
  • A team player but can work independently too.
  • Multi-tasking and time-management skills, with the ability to prioritize tasks.

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