Production Chemist - Sterile Manufacturing

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