Job Code: SPH-CSV01-2024

Validation Lead

Role Overview: The Validation Lead at Sophos IT Services is responsible for overseeing and executing the validation of new or upgraded safety systems, ensuring compliance with industry standards, regulatory requirements, and company policies. This role involves close collaboration with project teams, clients, and business analysts to finalize requirement specifications and ensure that the validated systems meet all necessary requirements. This is a remote role, providing flexibility and the opportunity to work from any location.

Location: Remote

Key Responsibilities:

  • Validation of Safety Systems
    • Provide application validation expertise on Adverse Event Reporting products, including safety system, and related modules.
    • Assist with the validation of new or upgraded safety systems, organizing and attending project meetings, and developing, executing, and approving validation deliverables.
  • Computer System Validation (CSV) Tasks
    • Own and be accountable for all CSV tasks for assigned projects, ensuring thorough and compliant validation processes.
    • Be accountable for authoring Validation Plan, Traceability Matrix, and Validation Summary Reports.
  • Strategic Planning and Implementation
    • Help in planning, strategizing, and implementing validation activities and processes according to industry best practices and company standards.
    • Follow cross-phase procedures and plans like Defect Management Plan, Change Control Procedure, Document Management Plan, and Training Plan.
  • Requirement Specifications
    • Work with project teams, clients, and business analysts to create and finalize requirement specifications, analyzing both business and functional requirements.
    • Conduct requirements analysis and risk assessment, profiling, and mitigation.
  • Compliance Assurance
    • Ensure that systems meet their requirements and comply with Sophos SOPs, client policies, procedures, and the defined validation plan.
  • Risk-Based Validation
    • Perform risk-based validation, reviews, and approvals of validation deliverables to ensure thorough risk management.
  • Authoring CSV Deliverables
    • Own and be accountable for authoring key CSV deliverables, ensuring accuracy and compliance with validation standards.
  • Validation Documentation
    • Contribute to and assist the validation team in authoring, dry-running, formally executing, reviewing, and approving IQ, OQ, PQ scripts, execution results, and validation summary documents.
    • Develop, execute, approve, and monitor qualification deliverables (IQ, OQ, MQ, PQ scripts and protocols, results, and reports) for GAMP Software categories.
  • Project Management Support
    • Assist in managing projects from a validation perspective, ensuring timely and quality delivery of validation tasks.
  • Client Liaison
    • Act as a liaison between project tracks and client process owners to ensure project delivery meets quality standards and deadlines.
    • Work closely with clients and vendors to support implementation and resolve product issues.

Minimum Education Qualification, Specialized Knowledge, and Skills:

  • Education:
    • BE/B.Tech/MCA from a recognized university/institute.
  • Experience:
    • Minimum of 5 years of professional experience in computer systems validation (CSV) within the pharmacovigilance (PV) domain.
  • Technical Skills:
    • Good understanding of the validation lifecycle and SDLC models.
    • Experience in performing and leading core validation tasks, including 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 validating GxP regulated systems and managing change control processes.
    • Familiarity with SQL.
    • Well-versed with various SDLC models, Software Test lifecycle, and Defect Management Life Cycle.
    • Knowledge of the Pharmaceutical / Life Sciences / Drug Safety domain.
  • Additional Skills:
    • Excellent communication and interpersonal skills.
    • Ability to multi-task and work well under pressure.
    • Commitment to excellence and high-quality standards.
    • Adaptability, flexibility, and willingness to work within changing priorities and time zones.
  • Preferred Skills:
    • Experience with Drug Safety Products from Aris Global/Oracle – ArisG/Argus or associated modules like AgExchange/ESM or Safety Mart/Insight.
    • Knowledge of regulatory guidelines from the Food and Drug Administration (FDA) and EMEA.
    • Hands-on experience with testing tools like HP Quality Center.
    • Understanding of RDBMS concepts and working knowledge of writing SQL queries.
    • Knowledge of the pharmacovigilance (PV) domain.

This remote Validation Lead role is pivotal in ensuring the quality and compliance of safety systems, contributing to the overall success of Sophos IT Services by adhering to stringent validation standards and regulatory requirements.

 ​How to Apply

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