Analyst/Lead – CSV/QA

Job Type:



Multiple Locations in India


8 Years


Best in Industry

  • At a minimum, following activities are required to be performed;
  • Validation and Qualification activities for the infrastructure, systems and processes for GxP compliance throughout GENINVO.
  • Oversee the Organization’s quality assurance organization to insure efficiency, quality, service, and cost-effective management of resources.
  • Work Closely with QA Manager on GxP audit programs for internal and external facilities as well as vendors and sub-contractors. This will include all study/project audits, any deviations, CAPA and subsequent reporting programs that advise the study/project director for potential impact.
  • Work Closely with QA Manager on managing client issues and expectations with regards to organizational quality systems.
  • Review of Project/Study documents for accuracy and completeness.
  • Co-ordinate with the development staff to assure that the quality level and standard operating procedures within the organisation are implemented into the study/project from inception till end.
  • Investigating customer complaints.
  • Perform other roles and responsibilities as assigned by the senior management
  • Bachelor’s degree from a reputed university preferably in life science related fields
  • Must have excellent knowledge of cGxPs, Quality standards, industry best practices and regulatory affairs for life sciences and IT processes.
  • Expertise in regulatory affairs and requirements for clinical research processes.
  • Sound knowledge of aspects of SAS programming, project management, pharmacovigilance systems, clinical data management, data submissions, clinical trial monitoring.
  • Strong capability to execute audits, facilitate and drive investigations, root cause analysis, and corrective and preventive actions.
  • Good understanding of quality and project management methodologies.
  • Excellent knowledge of SDLC methodologies, software testing and validation & verification
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