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. |