Executive- Antibodies- Production
yashrajbio
Executive- Engineering (QMS)
yashrajbio· Engineering
About this role
Position: QMS Executive – Engineering Department
Purpose of the Role:
To establish, maintain, and continuously improve the Engineering Quality Management System (QMS) in compliance with cGMP, Schedule M, WHO-GMP, ISO and other applicable regulatory requirements. The role ensures that all engineering documentation, Preventive maintenance, supporting to qualification, validation activities and quality records are properly controlled and compliant.
Key Responsibilities
Engineering QMS:
Prepare, review, revise, and maintain Engineering SOPs, formats, work instructions, and policies.
Ensure timely review and revision of controlled documents.
Maintain document control as per QMS requirements.
Deviations, CAPA & Change Control
Initiate and investigate engineering deviations.
Prepare root cause analysis (RCA) using appropriate quality tools.
Implement and monitor CAPA effectiveness.
Coordinate engineering change control activities.
Qualification & Validation
Prepare and review DQ, IQ, OQ, PQ protocols and reports.
Support qualification of utilities, equipment, and HVAC systems.
Coordinate periodic requalification activities.
Preventive Maintenance & Calibration
Ensure preventive maintenance schedules are followed.
Monitor calibration status of engineering instruments.
Maintain PM and calibration records for audit readiness.
Audit & Compliance:
Participate in internal, customer, and regulatory audits.
Prepare engineering documentation required during audits.
Ensure timely closure of audit observations.
Documentation:
Maintain engineering logbooks and records.
Ensure proper documentation of maintenance, breakdowns, and utility operations.
Archive engineering records as per document retention policy.
Training:
Conduct QMS and GMP training for engineering personnel.
Maintain training records and competency assessments.
Risk Management:
Perform Quality Risk Management (QRM) for engineering activities.
Support implementation of risk mitigation measures.
Timely closure of deviations and CAPAs.
Change control closure within target timelines.
PM and calibration compliance.
Audit observation closure.
Documentation compliance.
Indenting:
Prepare indent for all engineering related items
Coordinate with procurement as well as Engineering team for any hurdles
Qualification and Experience:
B.Pharma
Experience
3–5 years of experience in Engineering QMS within a pharmaceutical, biotechnology manufacturing company.
Required Skills
Good knowledge of cGMP, Schedule M, WHO-GMP, and regulatory requirements.
, deviations, CAPA, change control, and document management.
Knowledge of qualification and validation activities.
Strong documentation and communication skills.
Proficiency in Microsoft Office and electronic QMS systems.
Frequently Asked Questions
Is the salary disclosed for the Executive- Engineering (QMS) position at yashrajbio?
The salary for this Executive- Engineering (QMS) role at yashrajbio is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the Executive- Engineering (QMS) position at yashrajbio located?
This Executive- Engineering (QMS) role at yashrajbio is based in Navi Mumbai, MH, India. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the Executive- Engineering (QMS) role at yashrajbio full-time or part-time?
This is listed as a FULL TIME position. It is posted as a Executive- Engineering (QMS) role in the Engineering department at yashrajbio.
Which team or department does the Executive- Engineering (QMS) at yashrajbio belong to?
This Executive- Engineering (QMS) position is part of the Engineering department at yashrajbio. See the full job description for more information about the team structure and responsibilities.
How do I apply for the Executive- Engineering (QMS) position at yashrajbio?
Click the "Apply Now" button on this page. You will be redirected to yashrajbio's official application portal hosted on keka where you can submit your application directly.
When was the Executive- Engineering (QMS) job at yashrajbio posted?
This Executive- Engineering (QMS) position at yashrajbio was posted on Jul 30, 2026. Apply as soon as possible — early applications are often reviewed first.
Executive- Engineering (QMS)
yashrajbio
You'll be redirected to yashrajbio's official application page on keka.