Company Introduction
Rusan Pharma is an established pharmaceutical manufacturer focused on regulated API production for domestic and international markets.
Core Responsibilities
- Review batch manufacturing records, analytical reports, and logbooks against approved SOP files.
- Inspect change control forms, investigation sheets, and CAPA records stored in QMS systems.
- Examine raw material and finished API release documents before batch disposition.
- Verify audit observation trackers and closure evidence maintained in compliance files.
- Check validation master plans, qualification reports, and calibration schedules for completeness.
- Assess stability study data sets and APQR documents archived in quality repositories.
Skills & Technical Exposure
- cGMP, ICH, USFDA, EU GMP, and WHO guideline documents.
- QMS modules covering change control, OOS, OOT, and CAPA.
- ALCOA+ data integrity assessment tools.
- Validation, qualification, and calibration documentation.
- Stability chambers, trend charts, and APQR formats.
Experience Context
- Work environment includes regulated API manufacturing plants with multiple production blocks.
- Daily scope covers review of commercial batches, laboratory data, and validation records.
- Without this role, regulatory filings weaken and audit readiness collapses across the site.
How to Apply
sunil.namdev@rusanpharma.com