Compliance and Quality Management Systems (QMS)
- Enforce current Good Manufacturing Practices (cGMP), data integrity, and global regulatory standards (USFDA, EU GMP, MHRA).
- Oversee the generation, review, and approval of Standard Operating Procedures (SOPs), change controls, and risk assessments.
- Manage investigations for Out-of-Specification (OOS), Out-of-Trend (OOT) results, and plant deviations.
Manufacturing Operations and IPQA Oversight
- Lead line clearances, stage-wise verifications, and in-process quality checks for OSD (tablets, capsules) and sterile injectable lines.
- Verify critical manufacturing documents including Batch Manufacturing Records (BMR) and Batch Packing Records (BPR).
- Monitor cleanroom environments, HVAC systems, and process compliance specific to sterile and non-sterile areas.
Validation, Qualification, and Audits
- Provide quality approval for process validation, cleaning validation, and equipment qualification.
- Supervise specialized sterile testing requirements such as media fill validations for injectable manufacturing.
- Lead internal self-inspections and face external regulatory or customer audits with targeted Corrective and Preventive Actions (CAPA).
Pay: ₹100,000.00 - ₹120,000.00 per month
Benefits:
- Flexible schedule
- Food provided
- Health insurance
- Leave encashment
- Life insurance
- Provident Fund
- Work from home
Education:
Experience:
- QA/QC: 10 years (Required)
Work Location: In person
