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11 Sophos IT Services Jobs
Validation Analyst
Sophos IT Services
posted 3mon ago
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Job Description
The Validation Analyst at Sophos IT Services is responsible for supporting the validation of new or upgraded safety systems, ensuring compliance with industry standards, regulatory requirements, and company policies. This role involves collaborating with project teams, clients, and business analysts to finalize requirement specifications and ensure that the validated systems meet all necessary requirements.
Key Responsibilities:
- Support Validation Activities
- Assist with the validation of new or upgraded safety systems, organizing and attending project meetings, and developing, executing, and approving validation deliverables.
- Provide application validation expertise on Adverse Event Reporting products, including safety system and related modules.
- Computer System Validation (CSV) Tasks
- Participate in 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.
- 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.
- Ensure that systems meet their requirements and comply with Sophos SOPs, client policies, procedures, and the defined validation plan.
- Assist in performing risk-based validation, reviews, and approvals of validation deliverables to ensure thorough risk management.
- Contribute to authoring key CSV deliverables, ensuring accuracy and compliance with validation standards.
- Validation Documentation
- Assist 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.
- Support 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.
- Experience:
- 2-3 years of professional experience and strong knowledge with real-time experience in Computer System Validation / Software Testing / System Implementation in the Life Sciences industry.
- Technical Skills:
- Good understanding of the validation lifecycle and SDLC models.
- Experience in 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.
- 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.
- Excellent communication and interpersonal skills.
- Ability to multi-task and work well under pressure.
- Commitment to excellence and high-quality standards.
- Adaptability, openness to flexibility, and readiness to work with shifting priorities and across different 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 Validation Analyst role is crucial 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.
Employment Type: Full Time, Permanent
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