Validation Manager

2 days ago

Bengaluru, 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 Manager – Validation 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 Manager will lead and oversee all validation activities across global sites, ensuring alignment with corporate quality standards and international regulatory requirements.This role requires a strong foundation in Computer System Validation (CSV)CSV: Strong knowledge of FDA, GAMP 5, and global regulations (US, EU, TGA; Japan a plus) and broad experience in Equipment/Utility Qualification and/or Process, Cleaning, and Method Validation.The ideal candidate will demonstrate strong leadership, cross-functional collaboration, and the ability to design and implement global validation strategies.Key Responsibilities- Lead validation projects across global manufacturing and R&D facilities.- Define and implement the Validation Master Plan, SOPs, and global quality standards.- Ensure full compliance with cGMP, ISO, WHO, and applicable regulatory frameworks.- Review and approve validation protocols, reports, and risk assessments.- Manage and mentor site validation teams through Communities of Practice (COP) and structured training programs.- Provide strategic guidance during audits, CAPA, and change control processes.- Coordinate with cross-functional teams (Quality, Engineering, Manufacturing, IT) to ensure seamless project execution.- Drive continuous improvement initiatives to strengthen validation compliance and efficiency.Core Expertise Areas- Computer System Validation (CSV): Expert knowledge of FDA 21 CFR Part 11, Annex 11, GAMP 5, and other global standards.- Equipment/Utility Qualification: Strong understanding of IQ/OQ/PQ, FAT/SAT, and risk-based validation approaches.- Process/Cleaning/Method Validation: Experience with oral solid, topical, and spray dosage forms preferred.Profile Requirements- Bachelor’s or Master’s degree in Engineering, Pharmacy, or Life Sciences.- 10+ years of experience in pharmaceutical validation (FMCG experience less preferred).- Proven leadership experience managing cross-functional validation teams.- Strong knowledge of global regulatory requirements and audit readiness.- Excellent communication, documentation, and project management skills.What We Offer- A strategic leadership role supporting a leading global pharmaceutical organization.- Exposure to international validation frameworks and advanced compliance systems.- Hybrid work flexibility with a long-term contract-to-hire pathway.- A collaborative, growth-oriented environment within Elongo.

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