Job Description

Detailed :


• To adhere with the cGMP principles and to maintain them in an effective manner.


• Follow the implemented quality system.


• Operate the production equipment and monitor the production process as per SOP and BMR.


• Follow the production schedules.


• Follow the safety procedure.
• Collaborate with cross functional departments to avoid production interruption.
• Train new employees on production process and equipment.



Specific :


• To perform operations related to Aseptic Filling as per the production plan.


• To Perform related to aseptic filling area vial line and ampoule line


• Preparation and filtration of disinfectants required for Area cleaning as per the procedures.


• Area cleaning and maintaining the state of clean-rooms Class-A, B, C, D and Unclassified areas.


• To operate and clean the equipment, instrument or accessories used during the routine production activities as per the SOP.


• To perform operations related Machine parts cleaning as per the production plan and as per the Instruction of Supervisor/Designee.


• To perform operations related to autoclave unloading and aseptic Handling of Sterilized Items as per the production plan and requirement.


• Machine parts Assembling in the filling line and filling operations during the media fill and batch production process in the class - B Area.


• To adhere with the cGMP principles and follow the Standard Operating Procedure as defined.


• Data Integrity within work environment without fail as per the defined procedure.


• Handle waste and rejects as per procedure


• To assist in other unit operations as and when required or as instructed by the Supervisor/Manager





Core Competencies:


• Disciplined, Open for new learnings at the workplace.


• Good on Process Compliance & implementation skills.


• Basic command in English.


• Responsible in approach, high on Accountability & Ownership.


• Strong understanding and practice of 'cost consciousness'.


• Good in Time & Task Management.



Qualification/Functional Knowledge:


• Diploma/Degree in science/Chemical Engineering/Pharmacy.


• Functional knowledge of pharmaceutical industry, understand the operation process.


• Knowledge with cGMP principles