Engineering  Department Responsibility in Pharmaceuticals


Below are the responsibilities of Engineering personnel in Pharmaceutical Industry (But not limited To)

1. To follow Good Engineering Practice.
 
2.Preparation and Review of departmental SOPs
 
3. Preparation and Review of PM schedule, checklist and attending breakdown.
 
4. Observation and Guideline in installation activities of new equipment’s or projects at site.
 
5. Implementation of SAP
 
6. To review and undertake audits of vendor quality management system.
 
7. Review and implementation of Technical Agreement.
 
8. New vendor developments for different engineering services and follow up.
 
9.To witness calibration and validation activities and review of calibration certificates.
 
10. Support in installation activities of equipment’s.
 
11. Validation and Review of Site master plan and Coordination with contract persons
 
12.Preparing all drawings and related system engineering documents, such as :
P & I drawings
Utility drawing such as HVAC, Water system
Building and Room Drawings
Maintenance Requirements
Operational Manuals
Equipment Component Identification
Identification of Calibration Requirements
Equipment Installation and System Construction Procedures.
 
13. Co-ordination of the calibration activities for all critical instruments as identified by the validation team.
 
14. Executing, Installation Qualification and Operational Qualification tasks and assisting in the execution of Performance Qualification.
 
15. Maintenance of process & utility equipment.
 
16. Responsible for handling of change control, deviation, and incidents within the department.
 
17. To ensure the ALCOA Data Integrity Checks.

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