The Production Chemist is responsible for executing and monitoring manufacturing operations of Active Pharmaceutical Ingredients (API) in compliance with approved processes, cGMP, safety, and regulatory requirements, ensuring quality, productivity, and cost-effective operations.
Key Responsibilities
Manufacturing Operations
Execute API manufacturing processes as per approved Batch Manufacturing Records (BMRs).
Operate reactors, centrifuges, dryers, filters, and other production equipment.
Monitor critical process parameters and ensure adherence to defined limits.
Handle scale-up activities under supervision.
Documentation & Compliance
Complete BMRs, equipment logbooks, and other GMP documentation accurately and timely.
Ensure compliance with cGMP, SOPs, and regulatory guidelines (USFDA, EU-GMP, WHO-GMP as applicable).
Support audits and inspections by regulatory authorities and customers.
Quality & Safety
Follow safety procedures, MSDS, and EHS guidelines during operations.
Ensure proper handling, storage, and disposal of chemicals and solvents.
Report deviations, incidents, and OOS/OOT results promptly.
Coordination & Communication
Coordinate with Quality Control, Quality Assurance, Engineering, and EHS teams.
Ensure smooth shift handover and effective communication with team members.
Train and guide junior chemists and operators.
Educational Qualification
B.Sc / M.Sc in Chemistry or Organic Chemistry
B.Pharm / M.Pharm (Pharmaceutical Chemistry) preferred
Experience
5-8 years of relevant experience in API manufacturing (experience range can be adjusted)
Hands-on experience with GMP-regulated API plants preferred
Skills & Competencies
Strong knowledge of API manufacturing processes
Understanding of cGMP and regulatory requirements
Ability to read and interpret BMRs and SOPs
Good documentation and communication skills
Awareness of industrial safety and EHS practices
Willingness to work in shifts
Key Performance Indicators (KPIs)
Batch completion as per plan and yield targets
Compliance with GMP and safety standards
Reduction in deviations and incidents
Documentation accuracy and audit readiness
Job Types: Full-time, Permanent
Pay: ₹30,000.00 - ₹35,000.00 per month
Benefits:
Health insurance
Paid sick time
Paid time off
Provident Fund
Work Location: In person
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