Job code: SPH-CSV01-2019

Essential Duties And Responsibilities:

  • Assist with validation of new or upgraded safety systems which may include tasks such as organizing and/or attending project meetings, developing, executing and approving validation deliverables.

  • Own and be accountable for computer system validation tasks for the assigned projects.

  • Help in planning, strategizing and implementing the validation activities and processes as per industry best practices and company standards

  • Work with the project / client / BA teams to create and finalize the requirement specifications including analysis of business and functional requirements

  • Ensure that the system meets its requirements and is compliant with Sophos SOPs, applicable client policies and procedures, and the requirements as defined in the validation plan

  • Perform risk-based validation, reviews and approvals of validation deliverables

  • Own and be accountable for authoring key CSV deliverables

  • Contribute and/or assist the validation team (based on project requirement and team structure) in authoring, dry-run, formal execution, review and approval of IQ, OQ, PQ scripts, execution results and validation summary documents

  • Assist in managing the projects from validation perspective.

  • Liaison between project tracks and client process owners to ensure that project is delivered on time and with quality


Minimum Education Qualification, Specialized Knowledge and Skills: 

  • Bachelor’s Degree or equivalent preferably in a science or information technology discipline.

  • Minimum 5 years of professional experience in Computer systems validation (CSV) within PV / Drug Safety domain.

  • Good understanding of validation life cycle and SDLC models.

  • Prior experience of performing and leading core validation tasks including but not limited to requirement analysis, validation planning, test data preparation, test case execution, bug logging and reporting, preparing and reviewing test protocols and test scripts (IQ, OQ, PQ), traceability matrices and summary reports.

  • Working knowledge of GAMP5, CFR Part 11 guidelines and regulations pertaining to Drugs, Biologics, Vaccines and Medical Devices.

  • Experience in validation of GxP regulated systems and change control processes.

  • Familiarity with SQL

Primary Work Location

United States


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