Biocon Biologics | Documentation and HVAC validation

1 day ago


bangalore, India Biocon Biologics Full time

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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