Senior Quality Analyst

Audit Documentation:

Role Purpose:

To manage and control all quality-related documentation in the pharmaceutical manufacturing unit, ensuring full compliance with CDSCO (Central) and State Government regulations. The Senior Quality Analyst will keep the site audit-ready by maintaining accurate, complete, and compliant records.

Key Responsibilities:

• Prepare and organize all documentation required for CDSCO and State FDA inspections.
• Maintain audit-ready files, records, and logs at all times.
• Ensure timely and accurate responses to audit document requests.
• SOP & Master Documents:
• Draft, review, update, and control Standard Operating Procedures (SOPs).
• Manage issuance and control of master documents (BMR, BPR, specifications, test methods).
• Ensure Good Documentation Practices (GDP) across all departments.
• Batch Records & Logs:
• Review batch manufacturing and packaging records for completeness and correctness.
• Verify logbooks, forms, and data entries before final approval.

Job Type: Full-time

Pay: From ₹70,000.00 per month

Work Location: In person

Speak with the employer
+91 9990928598