Company Introduction
Hetero Labs is a large-scale pharmaceutical manufacturing organization with integrated facilities supporting regulated domestic and international markets.
Core Responsibilities
- Conduct line clearance on compression, coating, and packing equipment using approved IPQA checklists.
- Record in-process checks for weight variation, hardness, friability, and disintegration in BMR and BPR files.
- Verify critical manufacturing parameters on shop floor instruments against approved batch records.
- Review completed batch documentation, logbooks, and annexures before batch release movement.
- Document change control records, investigation reports, and CAPA forms within the quality system.
- Witness process validation and technology transfer batches with real-time documentation capture.
Skills & Technical Exposure
- Batch Manufacturing Records and Batch Packing Records.
- In-process quality check instruments for solid oral dosage forms.
- Quality management systems for change control, CAPA, and investigations.
- cGMP and GDP compliance documentation.
- Process validation and exhibit batch reports.
- Audit observation response records.
Experience Context
- Work is performed on the shop floor of an OSD pharmaceutical manufacturing plant.
- Daily exposure includes multiple commercial batches running on parallel production lines.
- Absence of this role leads to incomplete batch documentation and delayed regulatory readiness.
How to Apply
Ashok.c@hetero.com