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
- Strong understanding of GMP documentation practices.
- Knowledge of ALCOA+ principles.
- Good 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
