- Deviation Management: Documenting, brainstorming, and investigating process anomalies to prevent recurrence.
- CAPA Implementation: Driving Corrective and Preventive Actions to address root causes and minimize risks in aseptic processing.
- Change Control: Assessing, approving, and documenting changes to equipment, materials, or processes.
- Documentation Review: Reviewing Batch Manufacturing Records (BMR), Batch Production Records (BPR), and logbooks.
- Data Integrity: Ensuring compliance with ALCOA+ principles across all manufacturing operations.
- Audit Readiness: Supporting internal and external audits and responding to regulatory observations.
- Training Management: Ensuring production staff are qualified on Standard Operating Procedures (SOPs) and cGMP.
- Area Compliance: Monitoring environmental parameters (e.g., Differential Pressure, RH, temperature) and equipment cleaning.
Pay: ₹45,000.00 - ₹55,000.00 per month
Benefits:
- Flexible schedule
- Health insurance
- Leave encashment
- Life insurance
- Provident Fund
Education:
Experience:
- Qms production: 7 years (Required)
Work Location: In person
