Job Description:

Purpose
Prime representative from the Engineering & Maintenance department for all QMS-related activities.
This role ensures timely execution, tracking, and closure of Engineering QMS elements including Change Controls,
Deviations, CAPA, Equipment & HVAC.
Qualification, Calibration Activities, and internal self-inspection follow-ups.
This role ensures that all documents comply with GMP, GDP, regulatory expectations, internal standards, and audit readiness.

Position / Job Title
Sr. Executive - Calibration & Qualification, Engineering
Department
Engineering/Technical services

Reporting To
Assistant General Manager, Engineering

Location
Pithampur
Years of Experience
07–10 years of experience in QA and technical documentation. Minimum 5 years in a core QMS role within a
pharmaceutical formulation manufacturing facility dosage forms solid & semi solid

Job Responsibilities /
Deliverables
QMS Coordination & Compliance
Act as the Engineering representative for all QMS workflows, ensuring timely initiation,
tracking, and closure of: Change Controls,



Deviations, CAPAs, Risk Assessments, Investigations related to Engineering processes.
Ensure all Engineering and Maintenance QMS records meet USFDA, GMP, and ALCOA++ standards.
Maintain and monitor QMS trackers, ensuring zero overdue actions and timely escalation where required. Qualification & Validation (Equipment & HVAC)

Coordinate the preparation, review, and execution support
for Equipment IQ/OQ/PQ and HVAC qualification activities. Ensure qualification documents are accurate, complete, and compliant with site validation SOPs and regulatory expectations. Maintain the master inventory of all qualification documents and ensure periodic review and updates.

Calibration & Maintenance Documentation
Track calibration due dates, schedules, and ensure timely closure of calibration activities.
Ensure calibration records, reports, and certificates are maintained as per ALCOA++ principles.
Coordinate with calibra

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