Role & responsibilities

Required Skills and Experience
Strong hands-on experience in CSV and CSA activities for GxP-regulated computerized systems.
Positive understanding of regulatory requirements including GxP, FDA 21 CFR Part 11, EU Annex 11, GAMP 5, data integrity principles, and validation lifecycle expectations.
Experience in validation documentation preparation, review, execution, and approval.
Solid RIM business process knowledge, preferably across regulatory submissions, registrations, correspondence, commitments, publishing, tracking, and dossier management.
Experience supporting RIM system implementation, upgrade, enhancement, or migration projects.
Hands-on experience in data migration validation, including source-to-target mapping, migration testing, reconciliation, and defect management.
Experience with SAP integration validation or validation of system interfaces between enterprise applications.




Ability to understand business requirements, system configuration, workflows, data flows, and compliance impact.
Solid knowledge of audit trail, electronic signature, access control, security, and data integrity validation requirements.
Excellent documentation, analytical, communication, and stakeholder management skills.

Education and Qualifications
Bachelors or Masters degree in Life Sciences, Pharmacy, Biotechnology, Computer Science, Information Technology, Engineering, or a related discipline.
Relevant experience in healthcare, pharmaceutical, biotechnology, medical device, or other regulated life sciences environments.
Certification or training in CSV, CSA, GAMP 5, data integrity, or regulatory compliance will be an added advantage.

📌 Csv/csa Validation Engineer Hyderabad (India)
🏢 Cloudxtreme
📍 India