Production Chemist - Sterile Manufacturing

Aurolab · India

Key Responsibilities:

• Assign batch numbers for scheduled products and perform raw material weighing, review, and verification.
• Manage production materials in ERP, including indent requests, stock consumption, and stock-in activities.
• Raise in-process QC requests for batch analysis and preparation of BAK, Acetic Acid, and Citric Acid, and coordinate for respective reports/documents.
• Ensure line clearance in all production cleanroom and packing areas, including labeling, Domino printing, cartoning, and packing.
• Ensure all utensils and equipment used for batch preparation, filtration, and filling are sterilized, calibrated, verified, and available before production.
• Execute batch preparation as per production schedules and monitor filtration, filling, and packing activities.
• Maintain BMRs and relevant logbooks, and handle documentation related to deviations, change controls, regulatory requirements, and production SOPs.
• Plan daily production activities with the Line In-charge and coordinate with QC, Microbiology, and Maintenance teams.
• Plan and perform production validations, including cleanroom, cleaning, media fill, packaging, and sterilizer validations, in coordination with Production Managers and external agencies.
• Train production staff on manufacturing processes and sterility requirements, participate in internal/external audits, and ensure compliance with GMP, SOPs, and quality requirements.

Educational qualification: B.Pharm

Experience: 1 - 4 Years