08 Sep
|
Fido Pharma
|
Panchkula
08 Sep
Fido Pharma
Panchkula
- BMR/MFR Management
- Preparation, execution, review and closure of BMRs.
- Preparation/revision of MFRs based on approved process changes.
- Understanding of master vs. executed batch records.
- Batch numbering, document numbering and version control.
- Ensuring correct sequence of manufacturing activities.
- Batch Record Control
- Complete review of executed BMR 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.
- Process Documentation
- Documentation of critical process parameters.
- Recording of temperature, pH, RPM, pressure, air flow, time, volume, etc.
- Documentation of process hold times and stage-wise processing.
- Recording of equipment status and usage.
- Documentation of process interruptions and abnormal observations.
- Production Logbooks
- Equipment logbooks
- Area/room logbooks
- Fermenter logbooks
- Cleaning and usage records
- Utility-related production records
- Shift handover records
- Daily production activity records
- 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/documentation of approved corrective actions.
- Change Control Support
- Updating production documents following approved changes.
- MFR/BMR impact assessment from Production.
- Updating SOPs, formats and manufacturing instructions.
- Ensuring obsolete documents are removed from production use.
- 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.
- GMP/GDP Knowledge
- Strong understanding of GMP documentation practices.
- ALCOA+ principles.
- Valuable documentation practices for corrections.
- Prevention of backdating, blank entries and undocumented activities.
- Proper handling of controlled production documents.
Pay: ₹15,000.00 - ₹20,000.00 per month
Work Location: In person
📌 Production Incharge (Panchkula)
🏢 Fido Pharma
📍 Panchkula