Executive

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 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.

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.