Compliance & Documentation
Prepare, review, and approve SOPs, Batch Manufacturing Records (BMRs), and Batch Packaging Records (BPRs).
Ensure adherence to Good Manufacturing Practices (GMP) and regulatory guidelines (USFDA, MHRA, WHO, EU).
In-process Quality Assurance (IPQA)
Perform line clearance before starting batch production.
Monitor production & packaging processes, check critical control points, and document observations.
Ensure deviation control, change control, and corrective & preventive actions (CAPA).
Audits & Inspections
Support and participate in internal audits and external regulatory inspections.
Prepare necessary documents and ensure readiness of the plant for audits.
Training & Quality Culture
Conduct GMP and compliance training for production and support staff.
Promote a “right first time” and zero-defect culture.
Quality Systems Management
Handle deviations, OOS (Out of Specification), OOT (Out of Trend), and complaint investigations.
Manage document control, record retention, and electronic quality management systems (eQMS).
Batch Release & Product Quality
Review production and QC records before batch release.
Coordinate with QC for testing and QA for approvals.
| Category | Benefits |
|---|---|
| Financial & Statutory | Provident Fund (PF), Employee State Insurance (ESI), Gratuity, Annual Bonus, Performance Incentives. |
| Health & Wellness | Health insurance (for employee + dependents), Group life insurance, Accident insurance, Periodic medical check-ups. |
| Work-Life Balance | Paid leave (casual, sick, earned), National holidays, Maternity & paternity leave, Leave encashment. |
| Professional Growth | Training in GMP, USFDA, MHRA, WHO standards; Exposure to audits & regulatory inspections; Career growth from Officer → Manager → QA Head. |
| Workplace Support | Subsidized meals (canteen), Transport facility or travel allowance, Uniforms & safety gear where applicable. |
| Additional Perks (varies by company) | Shift allowance (for IPQA in shifts), Overtime pay if applicable, Relocation assistance for inter-plant transfers, Opportunities for global exposure (regulatory audits, international compliance projects). |