Role & responsibilities
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.
Regulatory Compliance &
USFDA Audit Readiness
cGMP &
ALCOA+ Compliance:

Ensure strict adherence to current Positive 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.
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.
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.
EHS (Setting, 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