Senior Quality Analyst

0 years

8 Lacs

Posted:4 hours ago| Platform: GlassDoor logo

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Work Mode

On-site

Job Type

Full Time

Job Description

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

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