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 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 environment.

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, and HVAC/Utility documentation.

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

Personal Attributes

Highly organized and detail oriented. Strong follow-up and communication skills.

Ability to influence cross-functional teams without authority.

Skilled, disciplined, and compliance-driven mindset.

📌 Senior Executive (Indore)
🏢 Rubicon Research
📍 Indore