qa - csv

3 days ago

Ahmedabad, Gujarat, India Elite Hr Services Ahmedabad Full time US$ 80,000 - US$ 1,20,000 per year

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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