Responsible for engineering compliance with respect to regulatory audits, customer audits, and internal audit requirements.
Ensure zero data integrity issues within the engineering department.
Prepare and maintain cGMP documents along with appropriate records.
Initiate and handle QMS documentation activities such as Change Control, Deviation, Risk Assessment, Investigation, Qualification, Validation, and CAPA.
Prepare and maintain preventive maintenance schedules, training calendars, calibration schedules, requalification schedules, and revalidation schedules to ensure compliance with approved documents and formats.
Execute and review equipment qualification, validation of HVAC, Air Compressor and Nitrogen Plant systems, preventive maintenance, and calibration of instruments.
Review logbooks related to HVAC systems, Water Systems, Boilers, Utilities, and instrument calibration activities.
Prepare and review engineering documents in compliance with cGMP requirements.
Prepare Standard Operating Procedures (SOPs) and Standard Calibration Procedures (SCPs) as per current cGMP practices.
Execute qualification, validation, and calibration activities of instruments in coordination with external agencies.
Coordinate with external agencies for the execution of scheduled activities.
Ensure timely indenting of spare parts for critical equipment and instruments and follow up with the purchase department and external agencies.
Ensure timely execution of all engineering activities as per approved schedules and planners.
Execute building and facility maintenance activities in coordination with external agencies.
Prepare and review engineering layouts and drawings.
Provide training to concerned personnel on engineering and compliance-related activities.
Approve Job Orders in the absence of the Head of Department (HOD).
Review cross-functional QMS documentation activities including Change Control, Deviation, Risk Assessment, Investigation, Qualification, Temperature Mapping of equipment and facilities, Validation, and CAPA.
Job Overview
Date PostedJun 10, 2026
Expiration DateMar 01, 2027
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