Company Introduction
Mangalam Drugs and Organics Limited is an established manufacturer in the active pharmaceutical ingredient segment with regulated market presence. The organization operates structured manufacturing blocks supported by documented quality systems.
Core Responsibilities
- Review batch manufacturing record and batch packing record documents against approved master copies and record observations in controlled logbooks.
- Verify standard operating procedures and validation protocols using document management system access and issue stamped copies for plant use.
- Inspect change control forms and corrective action preventive action records and record findings in tracking registers.
- Examine analytical data sheets and laboratory notebooks to confirm alignment with approved specifications and stability study files.
- Audit data entries within quality management software and compare entries with physical production and testing documents.
- Prepare internal audit checklists and compile inspection reports for submission to regulatory review files.
Skills and Technical Exposure
- Quality management system software
- Document control registers and archival files
- GMP guidelines and ICH documentation standards
- Validation protocols and master formula records
- Stability chambers and environmental monitoring reports
- Corrective action preventive action tracking tools
Experience Context
- Work inside an active pharmaceutical ingredient manufacturing plant handling multiple commercial scale batches each month.
- Exposure to controlled documentation rooms storing thousands of approved records and archival files.
- Engagement during regulatory inspections where compiled records determine product release status.
- Absence of this role leads to uncontrolled documentation gaps that can halt batch disposition and market supply.
How to Apply
kpandey@mangalamdrugs.com