Company Introduction
Hetero is a global pharmaceutical manufacturer with large scale facilities supporting regulated markets through structured quality systems.
Core Responsibilities
- Review completed batch manufacturing records using approved checklist documents before product release.
- Inspect audit preparation files by checking site master files, standard operating procedure binders, and training matrices.
- Verify corrective action records against closure evidence stored in controlled quality folders.
- Assess change control files by comparing approved forms with implementation records.
- Check market complaint investigation files using documented root cause tools and supporting attachments.
- Examine inspection readiness trackers and supporting evidence files for regulatory visits.
Skills and Technical Exposure
- Batch manufacturing records and product release checklists.
- Quality management system documentation and site master files.
- Corrective and preventive action documentation formats.
- Change control forms and implementation records.
- Regulatory inspection preparation trackers.
- Global regulatory guideline reference documents.
Experience Context
- Work is performed within active pharmaceutical manufacturing plants supporting solid oral and sterile dosage facilities.
- Documentation volumes include thousands of batch records, audit files, and compliance trackers.
- Without this role, inspection findings increase and product approvals face regulatory delays.
How to Apply
Send resume to pavani.ar@hetero.com or ashok.c@hetero.com