- Responsible for the planning and execution of the Engineering related activities.
- Operation & maintenance and daily monitoring of Electrical, Utilities &
- Process Equipments (like HVAC, Water System, Electrical Equipments and Process areas Equipment’s etc.).
- Maintenance and troubleshooting of Equipment’s / Instruments of injectable formulation facility
- Preparation of URS, Standard Operating Procedures, Purchase Requisition and Technical Recommendation for Utilities &
- Process Equipment’s etc. as per cGMP requirements.
- Ensure compliance of SOP’s and all related SOP’s training to be imparted to all concern department personnel.
- Preparation, Review &
- Implementation of Preventive maintenance schedule and Instruments calibration schedule of all equipment’s &
- Instruments of Utilities, Process equipment’s etc.
- Responsible for preparation of QMS documents (e.g., CCF, CAPA, Incident, QRM, QMS etc.).
- Prepare the indent/PR & maintain the critical mechanical/Electrical/Instrumentation spares, chemicals and consumable materials etc.
availability at site for avoid the breakdown time of utilities and Process equipment’s.
- Handling of external service provider agencies, preparation of service technical agreement and Bill checking and processing.
- Identify and Implementation of energy saving activities.
- Maintain online documentation and follow the SOP’s.
- Always readiness for represent of facility /Equipment / Documents for regularity audits.
- Responsible to coordinate with validation team for timely preparation/review of documentation & execution of all equipment’s, Qualification, requalification and validation activities. (Review of documents URS/DQ/FAT/SAT/IQ/OQ/PQ etc.).
- To maintain the document as per cGMP requirement.
- Preparation, Review &
- Implementation of drawings related to Plant, Machinery, Utility, HVAC etc.
- Responsible for compliance related to safety procedure, safety work place and achieve zero list time accident and compliance.