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🌟 Exciting Career Opportunity – Technology Transfer & Validation Expert
📍 Location: India – Pudupakkam
⏳ Job Type: Full-time
📅 Posted On: Today
🆔 Job Requisition ID: R001971
🔬 Role Overview
This role involves overseeing submission, validation, and troubleshooting activities, ensuring seamless coordination with cross-functional teams (CFTs), and managing protocol preparation, report evaluation, and project closure.
📌 Key Responsibilities
🚀 Technology Transfer & Validation Execution
✔️ Lead the technology transfer process for submissions, site transfers, and lifecycle management.
✔️ Evaluate, prepare, optimize, and finalize critical documents and processes for successful site implementation.
✔️ Align team members and CFTs through structured discussions to meet project timelines efficiently.
📊 Project Coordination & Risk Management
📅 Participate in daily, weekly, and monthly meetings to update project progress.
⚠️ Conduct risk evaluation and gap analysis, ensuring proper batch sizing and procurement readiness before project initiation.
📝 Prepare, review, and approve engineering, submission, and validation batch documents.
🤝 Collaborate in gate meetings and project discussions to drive project success.
🏭 Process Oversight & Regulatory Compliance
📌 Monitor engineering, submission, and validation batches as per market demands and project schedules.
🔬 Prepare placebos and coordinate QC testing based on project requirements.
📑 Support regulatory filings with necessary documentation.
🔎 Handle investigations to ensure high-quality documentation and strategic decision-making.
📢 Address CMC queries for timely product approvals and launch readiness.
💡 Provide commercial support throughout the entire product lifecycle.
🌍 Commitment to Diversity, Equity & Inclusion
At Endo, we believe that diversity is our strength! 🌈 We are committed to fostering an inclusive culture where every individual's perspective is valued. We celebrate diversity in race, ethnicity, gender identity, national origin, disability, and all other unique characteristics that make our team stronger.
🔹 Join us and be part of a team that drives innovation, quality, and excellence in the pharmaceutical industry!