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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 Computer Systems Validation Consultant based in India.
This role offers the opportunity to work at the intersection of technology, quality, and regulated life sciences environments, supporting the validation of critical computer systems used in pharmaceutical, biotech, and healthcare operations. You will play a key role in ensuring that GxP systems meet strict regulatory and compliance standards across their full lifecycle. The position involves hands-on execution of validation activities, technical documentation, and cross-functional collaboration with client and internal stakeholders. You will contribute to high-impact projects that directly support patient safety and product quality. Working in a consulting environment, you will gain exposure to diverse systems such as laboratory, clinical, ERP, and quality management platforms. The role suits a detail-oriented professional who thrives in structured, regulated environments and enjoys solving technical compliance challenges.
Accountabilities:
In this role, you will independently manage and execute Computer System Validation (CSV) activities across client engagements, ensuring systems are compliant with applicable regulatory standards. You will be responsible for preparing and executing validation deliverables while maintaining strong documentation discipline and client coordination.
- Author validation plans, user and functional requirements, test plans, IQ/OQ/PQ protocols, traceability matrices, and validation reports.
- Execute qualification protocols, document testing evidence, and manage deviations in alignment with GxP expectations.
- Develop compliance documentation including Part 11 and Annex 11 assessments and technical validation reports.
- Ensure proper validation of systems such as clinical, laboratory, ERP, automation, QMS, and medical device software systems.
- Collaborate with project managers and client stakeholders to align validation activities with project timelines and deliverables.
- Support CSV practice initiatives, internal programs, audits, and continuous improvement activities.
Requirements:
The ideal candidate brings strong hands-on experience in Computer System Validation within regulated pharmaceutical or healthcare environments, with the ability to work independently and communicate technical concepts clearly.
- Bachelor’s degree in Engineering, Science, IT, or related field (or equivalent experience).
- Minimum 3+ years of experience in Computer System Validation within GxP-regulated industries.
- Experience validating at least two system categories (e.g., clinical, laboratory, ERP, QMS, automation, or medical devices).
- Strong understanding of FDA GxP, 21 CFR Part 11, GAMP5, and EU regulatory guidelines.
- Ability to author and execute validation documentation with strong technical writing skills.
- Proficiency in Microsoft Office tools (Word, Excel, PowerPoint, Visio).
- Strong attention to detail, analytical thinking, and ability to manage documentation-heavy workflows.
Benefits:
- Exposure to global life sciences and regulated industry projects.
- Opportunity to work on diverse systems across clinical, lab, and enterprise platforms.
- Professional growth in validation, compliance, and regulatory consulting.
- Collaborative consulting environment with cross-functional learning opportunities.
- Hybrid/remote working flexibility depending on client requirements.
- Engagement in structured training, development, and industry best practices.
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