Production Chemist - Sterile Manufacturing

Aurolab; Madurai District; On-site; INR 300,000 - 600,000; Full time

Job summary

Aurolab in Tamil Nadu is seeking a Production professional to manage batch production activities in a GMP environment. You will assign batch numbers, weigh raw materials, manage ERP materials, and coordinate QC reports while ensuring line clearance in cleanrooms and packing areas.

The role requires B.Pharm with 1–4 years of experience in production, handling deviations, change controls, and SOPs, along with training staff and participating in internal/external audits.

Qualifications

• B.Pharm from a recognized college.
• 1–4 years of production/packaging experience in pharma.
• Knowledge of GMP, SOPs, and regulatory requirements.

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 prepare reports for chemicals like BAK, Acetic Acid, Citric Acid.
• Ensure line clearance in production cleanroom and packing areas, including labeling and cartoning.
• Ensure utensils and equipment are sterilized, calibrated, and ready before production.
• Execute batch preparation per schedules and monitor filtration, filling and packing.
• Maintain BMRs and logs; handle deviations, change controls, regulatory requirements, and SOPs.
• Plan daily production with Line In-charge and coordinate with QC, Microbiology, Maintenance.
• Plan and perform production validations (cleanroom, media fill, packaging, sterilizer) with managers and external agencies.
• Train staff on processes and sterility; participate in audits; ensure GMP and quality compliance.

Skills

GMP compliance

Documentation

ERP systems

Quality control

Education

B.Pharm

Tools

ERP software

Sterilization equipment

Job description

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