Validation Specialist

3 weeks ago

New Delhi, India Elongo Global Solutions Full time

About UsElongo is a growing and innovative organization delivering high-quality business support and talent solutions across diverse industries, including pharmaceuticals, 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 dynamic Validation Specialist to 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 RoleThe Validation Specialist will execute and support validation activities in alignment with global quality standards and regulatory requirements. The role requires solid expertise in Computer System Validation (CSV), along with hands-on experience in Equipment/Utility Qualification and/or Process, Cleaning, and Method Validation.The ideal candidate is detail-oriented, compliance-driven, and capable of independently managing validation deliverables across cross-functional teams.Key Responsibilities- Execute validation protocols and reports for systems, equipment, and processes. - Conduct Installation, Operational, and Performance Qualification (IQ/OQ/PQ) activities. - Support risk assessments, gap analyses, and remediation planning. - Maintain documentation in accordance with cGMP, GAMP 5, and company procedures. - Participate in audits, CAPA investigations, and deviation resolution. - Collaborate with cross-functional teams to ensure timely project completion. - Contribute to SOP development and updates as part of continuous improvement initiatives.Core Expertise Areas- Computer System Validation (CSV) – Mandatory: Hands-on experience with validation of GxP systems (MES, LIMS, ERP, QMS). - Equipment/Utility Qualification: Strong understanding of qualification lifecycle, FAT/SAT, and change control. - Process/Cleaning/Method Validation: Preferably for oral solid, topical, or spray forms.Profile Requirements- Bachelor’s or Master’s degree in Engineering, Pharmacy, or Life Sciences. - 8–10 years of experience in pharmaceutical validation. - Strong working knowledge of GAMP 5, FDA, and EU regulatory guidelines. - Excellent documentation, analytical, and organizational skills. - Self-driven, detail-oriented, and able to work effectively in a global matrix environment.What We Offer- Opportunity to work on international validation projects and systems. - Exposure to multi-site operations and diverse regulatory frameworks. - Hybrid work model offering flexibility and work-life balance. - Long-term engagement with growth and career advancement opportunities.

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