Purpose

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 related to Utilities.

This role ensures that all documents comply with GMP, GDP,

regulatory expectations, internal standards, and audit readiness.

Position / Job Title

Executive – Utilities Systems Coordinator

Department

Engineering/Technical services

Reporting To

Assistant General Manager, Engineering

Location

Pithampur

Years Of Experience

05–08 years of experience in QA and technical

documentation.

Minimum 4 years in a core QMS role within a

pharmaceutical formulation manufacturing facility

Dosage Form

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 calibration vendors and internal teams to

avoid any overdue calibration or audit observations.

Engineering Document Control

Maintain master list of all Engineering documents (SOPs,

work instructions, forms, checklists, drawings).

Ensure version control, document numbering, revision

history, and archiving as per GDP.

Prevent unauthorized use of obsolete documents by strict

withdrawal control.

Maintain master list of all Engineering documents (SOPs,

work instructions, forms, checklists, drawings).

Audit Preparedness & Self-Inspection

Support internal and external audits by providing Engineering

documentation, logs, and evidence as required.

Track and coordinate closure of self-inspection observations

related to Engineering.

Ensure Engineering files, equipment records, and logbooks

remain constantly audit-ready.

Address audit observations related to Engineering

documentation and support CAPA preparation.

Training & Awareness

Conduct training for Engineering team on document

standards, QMS procedures,



and good documentation

practices. Ensure relevant SOPs are understood and acknowledged by

all assigned personnel.

Ensure Engineering staff are trained on SOPs, QMS

processes, and documentation requirements.

Conduct awareness sessions on ALCOA++, deviation

handling, change control management, and engineering

documentation standards.

Verify training compliance for new or revised Engineering

documents.

Continuous Improvement

Identify gaps in Engineering documentation and propose

improvements.

Support implementation of digital systems (QMS software,

CMMS, e-logbooks) to improve traceability and compliance.

Promote culture of documentation discipline and right-first-

time practices within Engineering.

Ability to read equipment manuals, diagrams, and

HVAC/Utility documentation.

Proficiency in MS Office (Word, Excel, PPT) and QMS tools.

Qualifications Education

Bachelor's degree in mechanical / electrical /

Instrumentation / Chemical Engineering

Additional Notes Skills & Competencies

Strong understanding of Engineering & Maintenance

processes in a regulated pharma workplace.

Good knowledge of QMS systems (CC, CAPA, Deviation, Qualification, Calibration).

Familiarity with USFDA/GMP/ALCOA++ expectations.

Excellent documentation and coordination skills.

Ability to read equipment manuals, diagrams.

Personal Attributes

Highly organized and detail oriented.

Strong follow-up and communication skills.

Ability to influence cross-functional teams without authority.

Professional, disciplined, and compliance-driven mindset.

📌 Executive (Indore)
🏢 Rubicon Research
📍 Indore