Biocon Biologics | Documentation and HVAC validation
1 day ago
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.
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