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.

2. 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.

3. 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.

4. Production Logbooks

- Equipment logbooks
- Area/room logbooks
- Fermenter logbooks
- Cleaning and usage records
- Utility-related production records
- Shift handover records
- Daily production activity records

5. 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.

6. 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.

7. 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.

8. GMP/GDP Knowledge

- Solid understanding of GMP documentation practices.
- Knowledge of ALCOA+ principles.
- Positive documentation practices for corrections.
- Prevention of backdating, blank entries, and undocumented activities.
- Proper handling of controlled production documents.

Candidate Profile 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.

Contact Details

Mani Mahima

HR-Admin / EA

+91 82950 41964

[email protected]

FIDO PHARMA (P) LTD

SCO No. 45, 2nd Floor, Sector 4,

Panchkula (HR) – 134109, India www.fidopharma.com

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

Work Location: In person

📌 BMR/MFR Documentation Executive (Panchkula)
🏢 Fido Pharma
📍 Panchkula