Job Description
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)