We are looking for candidates with a minimum of 1 year of pharmaceutical industry experience, preferably with hands-on experience in BMR/MFR documentation, GMP/GDP practices, production documentation, and batch record review.

Key Responsibilities

1. BMR/MFR Management

Preparation, execution, review, and closure of BMRs.

Preparation and revision of MFRs based on approved process changes.

Understanding of master vs. executed batch records.

Batch numbering, document numbering, and version control.

Ensuring the correct sequence of manufacturing activities.

1. Batch Record Control

Complete review of executed BMRs from the Production perspective.

Identification of missing entries, overwriting, improper corrections, and incomplete fields.

Verification of signatures, dates, times, and equipment IDs.

Cross-checking actual quantities against approved quantities.

Yield calculation and reconciliation at different stages.

Tracking batch documentation from dispensing through final processing.

1. Process Documentation

Documentation of critical process parameters.

Recording temperature, pH, RPM, pressure, airflow, time, volume, etc.

Documentation of process hold times and stage-wise processing.

Recording equipment status and usage.

Documentation of process interruptions and abnormal observations.

1. Production Logbooks

Equipment logbooks

Area/room logbooks

Fermenter logbooks

Cleaning and usage records





Utility-related production records

Shift handover records

Daily production activity records

1. Deviation & Investigation Support

Identification and reporting of production-related deviations.

Preparation of factual production statements for investigations.

Collection of BMR, logbook, and process data for investigations.

Support in root-cause investigations from the Production side.

Implementation and documentation of approved corrective actions.

1. Change Control Support

Updating production documents following approved changes.

MFR/BMR impact assessment from the Production side.

Updating SOPs, formats, and manufacturing instructions.

Ensuring obsolete documents are removed from production use.

1. Production Planning Documentation

Batch planning and documentation readiness.

Checking availability of approved BMR/MFR before batch initiation.

Coordination with Warehouse/QC/QA for batch-document requirements.

Tracking batch status and documentation completion.

1. GMP/GDP Knowledge

Strong understanding of GMP documentation practices.

Knowledge of ALCOA+ principles.

Valuable documentation practices for corrections.

Prevention of backdating, blank entries, and undocumented activities.

Proper handling of controlled production documents.

Pay: ₹10,000.00 - ₹15,000.00 per month

Work Location: In person

📌 Production Manager (India)
🏢 Fido Pharma
📍 India