Engineering QMS

Yashraj Biotechnology; Navi Mumbai; On-site; INR 700,000 - 1,100,000; Full time

Job summary

Yashraj Biotechnology in Navi Mumbai is seeking an Engineering QMS specialist to manage SOPs, regulatory alignment, CAPA, and change control within the engineering function.

The role involves coordinating deviations, validating utilities and equipment, and ensuring timely audits and training records, backed by strong documentation and MS Office skills.

Qualifications

• Experience with cGMP, Schedule M and WHO-GMP.
• 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.

Responsibilities

• Prepare, review, revise, and maintain Engineering SOPs, formats, work instructions, and policies.
• Ensure timely document review, revision, and compliance with QMS requirements.
• Initiate and investigate engineering deviations, perform RCA, and implement CAPA.
• Coordinate engineering Change Control activities and ensure timely closure.
• Prepare/review DQ, IQ, OQ, PQ protocols and reports.
• Support qualification and requalification of utilities, equipment, and HVAC systems.
• Monitor preventive maintenance and calibration schedules and maintain records.
• Participate in internal, customer, and regulatory audits and ensure timely closure of observations.
• Maintain engineering logbooks, maintenance, breakdown, and utility records.
• Conduct QMS/GMP training and maintain training and competency records.
• Perform Quality Risk Management (QRM) and support risk mitigation activities.
• Ensure PM, calibration, documentation, deviation, CAPA, and Change Control compliance.
• Prepare engineering indents and coordinate with Procurement and Engineering teams to resolve related issues.

Skills

cGMP knowledge

Regulatory knowledge

CAPA management

Document management

Change control

Validation activities

QMS systems

MS Office

Tools

Electronic QMS

Job description

Role & responsibilities

Engineering QMS Key Responsibilities

• Prepare, review, revise, and maintain Engineering SOPs, formats, work instructions, and policies.
• Ensure timely document review, revision, and compliance with QMS requirements.
• Initiate and investigate engineering deviations, perform RCA, and implement CAPA.
• Coordinate engineering Change Control activities and ensure timely closure.
• Prepare/review DQ, IQ, OQ, PQ protocols and reports.
• Support qualification and requalification of utilities, equipment, and HVAC systems.
• Monitor preventive maintenance and calibration schedules and maintain records.
• Participate in internal, customer, and regulatory audits and ensure timely closure of observations.
• Maintain engineering logbooks, maintenance, breakdown, and utility records.
• Conduct QMS/GMP training and maintain training and competency records.
• Perform Quality Risk Management (QRM) and support risk mitigation activities.
• Ensure PM, calibration, documentation, deviation, CAPA, and Change Control compliance.
• Prepare engineering indents and coordinate with Procurement and Engineering teams to resolve related issues.

Preferred candidate profile

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.