Role Summary

Responsible for managing Calibration Systems, Engineering QMS, Utility Operations & Maintenance, and Project Execution in a GMP-compliant Oral Solid Dosage (OSD) facility. Ensures regulatory compliance, high equipment reliability, and uninterrupted manufacturing operations.

Key Responsibilities

Calibration Management

• Monitor and maintain calibration program for GMP-critical instruments.
• Ensure traceability (NABL/ISO 17025) and 100% compliance
• Handle OOT, deviations, and CAPA related to calibration
• Maintain records as per written procedures.

Engineering QMS

• Monitor Change Controls, Deviations, CAPA, and Risk Assessments related to Engg.
• Ensure compliance with cGMP and Data Integrity (ALCOA+)
• Prepare/review SOPs and applicable Engineering related documents.
• Support regulatory audits (NPRA, CQA, Internal)

Utility Operat...