Production Chemist

1 week ago

Hyderabad, India Kreative Organics Full time

The Production Chemist will be responsible for executing and monitoring API manufacturing processes, ensuring compliance with cGMP, SOPs, and regulatory guidelines. The role involves operating chemical process equipment, documentation, troubleshooting, and process optimization to achieve efficiency, safety, and quality standards.

Key Responsibilities & Duties:

  • Process Execution: Perform batch manufacturing activities in line with Standard Operating Procedures (SOPs), Batch Production Records (BPRs), and cGMP requirements.
  • Equipment Operation: Operate and monitor reactors, centrifuges, multi-mill, shifter, tray dryer, filtration systems, GLR, and SSR equipment.
  • Quality Assurance & Compliance: Coordinate with QA/QC teams for batch release, deviation handling, and ensure adherence to regulatory and quality standards.
  • Documentation: Maintain accurate production records, logbooks, and deviation reports ensuring data integrity and audit readiness.
  • EHS & Safety Compliance: Follow Environmental, Health & Safety (EHS) protocols, participate in safety drills, and ensure a safe work environment.
  • Process Optimization: Assist in scale-up, yield improvement, and continuous improvement initiatives for cost-effective production.
  • Troubleshooting & Maintenance: Identify and resolve equipment or process deviations in coordination with the engineering and maintenance teams.
  • Shift Management: Supervise shift operations, allocate tasks, and ensure smooth production workflow.

Qualifications & Experience

  • Education: B.Sc./M.Sc. in Chemistry or B.E. in Chemical Engineering.
  • Experience: 1 - 6 years in API production / pharmaceutical manufacturing.

  • Technical Skills:

  • Knowledge of GMP, GLP, ICH, and regulatory compliance.

  • Hands-on experience with clean room operations, batch documentation, and shift planning.
  • Familiarity with process safety, scale-up, and validation activities.

Preferred Attributes

  • Strong analytical, problem-solving, and decision-making skills.
  • Ability to work effectively in a fast-paced, regulated production environment.
  • Good communication, teamwork, and reporting skills.
  • Flexible to work in shifts and handle multiple tasks.

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