Senior Executive
Rubicon Research Limited
Date: 2 weeks ago
City: Indore, Madhya Pradesh
Contract type: Full time
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.
Dosage Form Solid & Semi solid
Job Responsibilities /
Deliverables
QMS Coordination & Compliance
Change Controls
Deviations
CAPAs
Risk Assessments
Qualification & Validation (Equipment & HVAC)
expectations.
Calibration & Maintenance Documentation
Engineering Document Control
Audit Preparedness & Self-Inspection
Training & Awareness
practices.
documentation standards.
Continuous Improvement
Additional Notes Skills & Competencies
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
Dosage Form Solid & Semi solid
Job Responsibilities /
Deliverables
QMS Coordination & Compliance
- Act as the Engineering representative for all QMS workflows,
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
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
expectations.
- Maintain the master inventory of all qualification documents
Calibration & Maintenance Documentation
- Track calibration due dates, schedules, and ensure timely
- Ensure calibration records, reports, and certificates are
- Coordinate with calibration vendors and internal teams to
Engineering Document Control
- Maintain master list of all Engineering documents (SOPs,
- Ensure version control, document numbering, revision
- Prevent unauthorized use of obsolete documents by strict
- Maintain master list of all Engineering documents (SOPs,
Audit Preparedness & Self-Inspection
- Support internal and external audits by providing Engineering
- Track and coordinate closure of self-inspection observations
- Ensure Engineering files, equipment records, and logbooks
- Address audit observations related to Engineering
Training & Awareness
- Conduct training for Engineering team on document
practices.
- Ensure relevant SOPs are understood and acknowledged by
- Ensure Engineering staff are trained on SOPs, QMS
- Conduct awareness sessions on ALCOA++, deviation
documentation standards.
- Verify training compliance for new or revised Engineering
Continuous Improvement
- Identify gaps in Engineering documentation and propose
- Support implementation of digital systems (QMS software,
- Promote culture of documentation discipline and right-first-
- Ability to read equipment manuals, diagrams, and
- Proficiency in MS Office (Word, Excel, PPT) and QMS tools.
- Bachelor’s degree in mechanical / electrical /
Additional Notes Skills & Competencies
- Strong understanding of Engineering & Maintenance
- Good knowledge of QMS systems (CC, CAPA, Deviation,
- Familiarity with USFDA/GMP/ALCOA++ expectations.
- Excellent documentation and coordination skills.
- Ability to read equipment manuals, diagrams, and
- Proficiency in MS Office (Word, Excel, PPT) and QMS tools.
- 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.
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