Executive- Engineering (QMS)

Yashraj Biotechnology Ltd.; Navi Mumbai; On-site; INR 600,000 - 1,200,000; Full time

Job summary

Yashraj Biotechnology Ltd. in Navi Mumbai seeks a QMS Executive for the Engineering Department to establish, maintain, and continuously improve the Engineering QMS in line with regulatory requirements. You will ensure proper control of engineering docs, preventive maintenance, and qualification/validation activities.

The role covers deviations, CAPA, change control, audit readiness, and training to engineering staff, with emphasis on precise record-keeping and compliance.

Qualifications

• B.Pharma with 3–5 years in engineering QMS within pharma/biotech.
• Knowledge of cGMP, Schedule M, WHO-GMP and regulatory requirements.
• Strong documentation and communication skills.
• Proficiency in MS Office and electronic QMS.

Responsibilities

• Prepare, review, and maintain engineering SOPs, formats, work instructions, and policies.
• Review controlled documents timely and ensure document control per QMS.
• Coordinate deviations, CAPA, and change control activities.
• Support qualification, validation, and periodic requalification.
• Manage preventive maintenance and calibration records for audit readiness.
• Participate in internal, customer, and regulatory audits and close observations.

Skills

cGMP knowledge

Audit readiness

Documentation

QMS

Education

B.Pharma

Tools

Microsoft Office

Electronic QMS

Job description

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.