Job Description

Department Details

Role Summary

1.Shall be able to handle shift activity and mechanical breakdowns and machine preventive maintenance.
2) Shall have the sterile equipment handling work experience ( Autoclave , Filling Line , Lyophilizer, HVAC )
3) Shall have hand on experience of HVAC Validation /Area Qualification activity.
4) Shall have knowledge of preparation of cGMP document ( SOP, Protocols , Planners, Change control , Deviation )
5) Able to handle the Audit ( Safety , GMP)
6) Shall have 5-10 years working in the process and Pharma industry experience
Basic for computer requirement.
7. He should able to Handle the team of 5 to 6 people
8. He should handle the cross-function team query of PM/BM of equipment.
9. He should have good communication skill .
10. He should have the knowledge of fill finish process equipment and aseptic practices.

1) Should have Knowledge Good documentation practices.
2) Basic Knowledge of Mechanical field.
3) Computer Basic Knowledge ( MS Word , Excel, Power point

Key Responsibilities

Key Responsibilities Required Day to day shift handling for mechanical shift.
Equipment Preventive maintenance and breakdown handling.
Routine checklist /planner /document filling.
Area qualification /HVAC periodic qualification execution and preparation.
Spare management
Following aseptic practices/ Gmp /GDP and safety practices on the workplace.
Deviation/ Change

Educational Qualifications

Required Education Qualification: Diploma
Required Experience: 1 - 10 years