Executive / Sr. Officer - Process Engineering (Indore Plant)

Responsibilities

• 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.