Executive- Engineering (QMS)

Keka Technologies Private Limited; Nanded District; On-site; INR 600,000 - 1,100,000; Full time

Job summary

Keka Technologies Private Limited in India is seeking an Engineering QMS professional to establish, maintain, and continuously improve the QMS in line with cGMP, Schedule M, WHO-GMP, ISO and other regulatory standards. You will manage documentation, deviations, CAPA, and qualification activities, ensuring audit readiness and regulatory compliance.

The role involves coordinating preventive maintenance, calibration, and training, while supporting audits and ensuring timely closure of observations

Qualifications

• 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.

Responsibilities

• 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.
• Initiate and investigate engineering deviations.
• Prepare root cause analysis (RCA) using appropriate quality tools.
• Implement and monitor CAPA effectiveness.
• Prepare and review DQ, IQ, OQ, PQ protocols and reports.
• Support qualification of utilities, equipment, and HVAC systems.
• Coordinate periodic requalification activities.
• Ensure preventive maintenance schedules are followed.
• Monitor calibration status of engineering instruments.
• Maintain PM and calibration records for audit readiness.
• Participate in internal, customer, and regulatory audits.
• Prepare engineering documentation required during audits.
• Ensure timely closure of audit observations.
• Maintain engineering logbooks and records.
• Archive engineering records as per document retention policy.
• Conduct QMS and GMP training for engineering personnel.
• Maintain training records and competency assessments.
• 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.

Skills

cGMP regulatory requirements

Deviations CAPA Change control

Documentation & communication

Qualification & Validation knowledge

MS Office & electronic QMS

Education

B.Pharma

Job description

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

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.

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.

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.