Engineering QMS|| Pharma

To maintain and implement the aspects of the quality management system.

Tracking to allow for proper correction of internal and external audit major/minor non conformance and improvement observation related to engineering department in accordance with plant.

Handling of deviation incident and investigation of engineering and maintain the effectiveness of corrective and preventive actions.

Perform the quality risk assessment and impact assessment with the interdepartmental coordination for major changes in facility.

Initiating and implementation of change control, planned and unplanned deviation related to engineering department through electronic quality management system software.

Maintain all documents of engineering department with respect to regulatory aspect and also maintain the data integrity of documents.

• Provide internal training for QMS function including organizational training and subject matter expertise for QMS compliance and process improvements.
• Timely close CAPA and CC action items task which is assigned to engineering team.
• Prepare calibration & Maintenance planner with documentation.
• Follow up and execution of routine activities like preventive corrective and breakdown maintenance.
• Prepare calibration schedule for Instrument develop, implement and maintain calibration procedure through SAP.
• Operation and maintenance of various electronic instruments like sensor, Controller, transmitter, weighing scale, Gauges etc.
• Troubleshooting in PLC of instruments used in FBP/FBD (Granulation), Coating Machine, Compressio Machine, BQS machine (Packing), BMS&EMS, water system&Utility etc.
• Vendor management as per requirement of material and Services.
• Provide support to the site in reviewing the calibration activity from product impact due to an out of calibration situation.
• Critical spare management skills for breakdown and planned maintenance.