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At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.
Are You Ready to Create Your Own Sunshine?
As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”
JOB DESCRIPTION:
Job Summary
Provide technical leadership for granulation processes and equipment (wet, dry/roller compaction, and fluid-bed systems), ensuring robust, compliant, and efficient operations across development, scale-up, and commercial manufacturing & operations at all sites of SGO.
Area Of Responsibility
Technical Expertise
• Act as the primary expert for high-shear mixers/RMG, fluid-bed granulators/dryers (FBD), roller compactors, milling and blending systems, bin handling, and closed transfer systems.
• Define and optimize critical process parameters (CPPs) and material attributes (CMAs) for consistent granule quality (PSD, LOD, porosity, flowability—Carr Index / Hausner Ratio).
Troubleshooting & Support
• Lead resolution of chronic issues: low yield, poor granule flow, inconsistent LOD, segregation, over/under granulation, capping/chipping in downstream compression.
• Execute structured RCA (5-Why, Fishbone) and implement permanent corrective actions.
• Should be able to handle troubleshooting and problem-solving, acting as the primary authority for resolving complex production issues, machine malfunctions, and deviations that arise during the granulation process.
• Should have capability for installation and commissioning of granulation equipment.
• Should have knowledge about instrumentation, calibration, and operation of components installed on granulation machines.
Process Optimization/Benchmarking
• Drive OEE improvement, cycle time reduction, and SMED for batch changeovers.
• Implement PAT tools (e.g., NIR moisture, torque/power trend analysis) and digital logging to stabilize batches.
Compliance & Validation
• Ensure adherence to cGMP, cleaning validation, cross-contamination control, containment (OEB levels), ATEX/dust explosion safety.
• Own equipment lifecycle: URS → FAT/SAT → IQ/OQ/PQ, change control, and periodic review; ensure 21 CFR Part 11 compliance for data integrity.
Training & Capability Building
• Ability to Train operators/maintenance on best practices: endpoint detection, sieving/milling, cleaning/line clearance, and safety protocols.
Vendor/OEM Management/Emerging Technologies
• Liaise with OEMs for upgrades, process audits, spares, retrofits (e.g., WIP/CIP, improved bowl designs, containment solutions).
• Candidate should have a flair to remain update on latest Trends and technologies in the field
Physical Requirements: Physically fit for extensive Travel
Technical Knowledge
• Granulation science: binder systems, torque/power curves, endpoint criteria, moisture profiles, PSD control, and downstream compressibility.
• Equipment qualification and validation; data integrity; cleaning validation; containment and ATEX.
• CI toolset: TPM, Lean, Six Sigma (Green/Black Belt preferred), SMED, Kaizen.
• Digital & Analytics: Comfortable with OEE dashboards, trend analysis, PAT signals, and batch data review for CPV.
• Soft Skills: Strong problem-solving, shop-floor presence, stakeholder influence, and vendor management.
*Work experience with Equipment manufacturers will be an added advantage
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