Engineering QMS

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.