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This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a GxP Systems Specialist based in India.
You will join a mission-critical quality and systems environment supporting regulated clinical trial operations and life sciences data integrity. This is a short-term but high-impact engagement focused on executing a complex data migration while ensuring full compliance with global regulatory standards. You will play a key role in maintaining validated systems and ensuring seamless information flow across platforms used in clinical research and quality management. The role requires strong technical ownership across enterprise content systems, with close attention to compliance, traceability, and documentation standards. You will collaborate with QA, IT, and project leadership teams to ensure systems remain inspection-ready throughout the transition. This position is ideal for a detail-oriented specialist who thrives in regulated environments and can deliver precision under tight timelines.
Accountabilities:
- Lead and execute a time-bound Box-to-Box data migration project, ensuring accurate transfer, validation, and integrity of regulated clinical data.
- Perform system administration duties across enterprise platforms including Box, SharePoint, and Ignite, ensuring stability and controlled access.
- Manage Computer System Validation (CSV) activities across clinical systems, ensuring full lifecycle compliance and audit readiness.
- Ensure adherence to regulatory frameworks including GxP principles, GAMP guidelines, and GCP requirements throughout all system and data operations.
- Support eQMS-related activities using systems such as ACE Software (by PSC), including configuration, optimization, and documentation support where needed.
- Collaborate closely with QA, IT Quality, and project leadership to ensure alignment on validation strategy and migration execution.
- Maintain detailed technical documentation, validation records, and migration reports to support regulatory inspections and audits.
Requirements
- Strong hands-on experience in Computer System Validation (CSV) within pharmaceutical, biotech, or clinical research environments.
- Proven system administration experience with enterprise platforms such as Box, SharePoint, and similar document management systems.
- Solid understanding of regulatory frameworks including GxP, GAMP, and GCP, particularly in relation to validated systems in clinical trials.
- Experience handling data migration projects, ideally involving eTMF or regulated clinical data environments.
- Familiarity with electronic Quality Management Systems (eQMS), with exposure to tools such as ACE Software (by PSC) considered a strong plus.
- Ability to operate in fast-paced, short-duration project environments with strong execution focus and minimal ramp-up time.
- Strong documentation, communication, and stakeholder coordination skills, particularly in cross-functional QA/IT settings.
- High attention to detail, strong analytical mindset, and ability to ensure compliance under strict regulatory expectations.
Benefits
- Competitive short-term contract compensation aligned with expertise and project scope.
- Fully remote working arrangement with structured project hours.
- Opportunity to contribute to a high-impact clinical systems migration in a regulated life sciences environment.
- Exposure to global standards in clinical data management and validation practices.
- Collaboration with experienced QA, IT, and regulatory professionals.
- Hands-on experience with critical compliance systems used in clinical research operations.
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