Compliance and Quality Management Systems (QMS)
Enforce current Valuable 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
Perks
Adaptable schedule
Food provided
Health insurance
Leave encashment
Life insurance
Provident Fund
Work from home