Validation Specialist

3 days ago

New Delhi, India Elongo Global Solutions Full time

About UsElongois a growing and innovative organization delivering high-qualitybusiness support and talent solutionsacross diverse industries, includingpharmaceuticals, life sciences, technology, and engineering. We partner with global enterprises to provide specialized professionals and managed services that drive operational excellence and compliance. As part of our continued growth, we are seeking an experienced and dynamicValidation Specialistto support our client’s pharmaceutical operations and global validation initiatives.Location:Hyderabad (Hybrid: 3 Days Office / 2 Days Remote) Engagement:18-Month Contract-to-HireAbout the RoleTheValidation Specialistwill execute and support validation activities in alignment withglobal quality standards and regulatory requirements. The role requires solid expertise inComputer System Validation (CSV), along with hands-on experience inEquipment/Utility Qualificationand/orProcess, Cleaning, and Method Validation. The ideal candidate isdetail-oriented, compliance-driven, and capable of independently managingvalidation deliverables across cross-functional teams. Key ResponsibilitiesExecute validation protocols and reports for systems, equipment, and processes. ConductInstallation, Operational, and Performance Qualification (IQ/OQ/PQ)activities. Supportrisk assessments, gap analyses, and remediation planning. Maintain documentation in accordance withcGMP, GAMP 5, and company procedures. Participate inaudits, CAPA investigations, and deviation resolution. Collaborate with cross-functional teams to ensure timely project completion. Contribute toSOP development and updatesas part of continuous improvement initiatives. Core Expertise AreasComputer System Validation (CSV) – Mandatory:Hands-on experience with validation ofGxP systems(MES, LIMS, ERP, QMS). Equipment/Utility Qualification:Strong understanding of qualification lifecycle,FAT/SAT, and change control. Process/Cleaning/Method Validation:Preferably fororal solid, topical, or spray forms. Profile RequirementsBachelor’s or Master’s degreein Engineering, Pharmacy, or Life Sciences. 8–10 years of experiencein pharmaceutical validation. Strong working knowledge ofGAMP 5,FDA, andEU regulatory guidelines. Excellentdocumentation, analytical, and organizationalskills. Self-driven, detail-oriented, and able to work effectively in aglobal matrix environment. What We OfferOpportunity to work oninternational validation projects and systems. Exposure tomulti-site operationsand diverse regulatory frameworks. Hybrid work modeloffering flexibility and work-life balance. Long-term engagement withgrowth and career advancement opportunities.

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