Role & responsibilities

1. Production Planning &
- Shop Floor Execution

- Batch Scheduling: Execute daily and weekly production schedules based on master planning to meet production and market delivery targets.

- Unit Operations: Oversee critical API manufacturing operations, including reaction kinetics, distillation, centrifugation, filtration, drying, micronization, and final cleanroom packing.

- Resource Optimization: Effectively allocate manpower across shifts, minimize equipment downtime, and optimize raw material and solvent consumption.

1. Regulatory Compliance &
- USFDA Audit Readiness

- cGMP &
- ALCOA+ Compliance:

Ensure strict adherence to current Good Manufacturing Practices (cGMP), ICH guidelines, and Data Integrity principles.

- Audit Representation: Act as a key technical representative during internal, customer, and regulatory audits, including USFDA, MHRA, and EU-GMP inspections.

- Cleanroom Controls: Ensure final API isolation activities comply with applicable cleanroom classification standards and cross-contamination control requirements.

1. Quality Management Systems (QMS)

- Documentation Review: Author, review, and ensure timely closure of Batch Manufacturing Records (BMRs), Batch Production Records (BPRs), and Standard Operating Procedures (SOPs).

- Deviations &




- Investigations:

Lead Root Cause Analysis (RCA) for process deviations, Out-of-Specification (OOS) results, and production incidents.

- CAPA &

- Change Control:

Develop and implement effective Corrective and Preventive Actions (CAPA) and manage formal Change Controls for process modifications.

1. Technology Transfer &
- Process Validation

- Scale-Up: Coordinate with the Process Development/R&D; and Technology Transfer teams for the seamless introduction and scale-up of current products.

- Validation Protocols: Execute process validation, equipment qualification (IQ/OQ/PQ), and cleaning validation activities to ensure regulatory compliance.

1. EHS (Environment, Health &
- Safety)

- Ensure safe handling of chemicals, hazardous/exothermic reactions, and solvent recovery operations in accordance with applicable industrial safety standards.

- Promote a zero-accident culture by ensuring proper PPE usage and strict implementation of Lockout/Tagout (LOTO) procedures during maintenance activities.

Preferred candidate profile

- 1015 years of relevant experience in API manufacturing

- Experience in a USFDA-approved manufacturing facility preferred

📌 Assistant Manager - Production (Tarapur)
🏢 IPCA
📍 Tarapur