Utility/Preventive Maintenance Senior Officer/Executive

Role & responsibilities

Follow & Implement the GMP, Safety norms and adhere to company's policy

Ensure compliance to safety standards, cGMP, good engineering practices and regulatory requirements

Preparation and review of Equipment and Systems qualification

Make design specification and ensure completion of qualifications. DQ, IQ, OQ.

Authorized to prepare and verify Department documents.

New equipment installation, commissioning of system's(Utility's) as applicable

Operation and Maintenance of HVAC systems

To ensure proper operation and monitoring of water systems, potable and purified water systems

To ensure proper operation and maintenance of chillers, nitrogen plants, air compressors, driers, cooling towers, boiler, thermic fluid system & pumps

Responsible for validating the HVAC, Nitrogen and Compressed air by coordination with external agency

Verification of Preventive maintenance, calibration schedules and activities

Knowledge on Change Controls, CAPA's and ERP (Enterprise Resource Planning)

Responsible for facing internal, customer and regulatory audits

Preparation and review of SOP's and Formats.

Handling of CCF's, deviations coordinate with Quality Assurance and Concerned departments

Any other works as directed by department HOD/Designee

Preferred candidate profile

Familiarity with utility operation & maintenance.

Documentation as per GMP requirements.

Perks and benefits

As per company norms