Engineering Executive

Role & responsibilities

• Prepare, review, issue, control and archive GMP documents.
• Prepare, review, update and verify engineering sop, formats, checklist and logbooks.
• Maintain preventive maintenance record, logbooks, equipment history cards.
• Ensure proper documentation control as per GMP requirements.
• Preparation and execution of equipment qualification activities as DQ, LQ, OQ, PQ.
• Coordinate and execute HVAC Validations, compressed air, purified water mapping, temperature.
• Support internal, external, customer and regulatory audits.
• Prepare audit responses and close observation within timelines.
• Handle engineering related change control, deviation, CAPA and close within timelines
• Prepare and maintain PM and calibration schedules as per approved procedures.