RESPONSIBILITIES: Primary responsibilities: Follow the established procedures and policies of the company. Preparation and execution of equipment qualification documents & activities. Preparation and execution of area validation documents & activities. Preparation of documents related to the engineering department, ie, SOP, Quality & EHS management. Issue of work permits. Preparing layouts related to facility, equipment, area & etc. Raising / taking change control, deviation and CAPA related to engineering department. Fill & verification of log sheets and checklist as described in the SOPs. Implementation of safety, cGMP & energy conservation measures. To implement & follow SAP in department. Coordinate for the smooth running of any audits (Internal and external) related to QMS and EHS management system. Ensure all the audit findings are closed within the stipulated time. Perform the required documentation like checklist and logbook updation. Adherence to standard operating procedures, Safety, cGMP and EHS requirements. Updating of department related documents as and when required. Preparation of various yearly planners for the department. Vendor and OEM follow ups for different related activities.Secondary responsibilities (Wherever applicable): Execution of routine, predictive, preventive, AMC, modification and breakdown maintenance activities. Ensure all equipment are operated and maintained as per manufacturer’s recommendation. Spares management and inventory control. To support departmental project related activities.
Job Title
Documentation and HVAC validation