Senior Executive

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 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, 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.
• Professional, disciplined, and compliance-driven mindset.