Machine Operators – Aspectic

Title: Machine Operators – Aspectic

Detailed Job Description:

1. To adhere with the cGMP principles and to maintain them in an effective manner.
2. Follow the implemented quality system.
3. Operate the production equipment and monitor the production process as per SOP and BMR.
4. Follow the production schedules.
5. Follow the safety procedure.
6. Collaborate with cross functional departments to avoid production interruption.
7. Train new employees on production process and equipment.

Specific Job Description:

1. To perform operations related to Aseptic Filling as per the production plan.
2. To Perform related to aseptic filling area vial line and ampoule line
3. Preparation and filtration of disinfectants required for Area cleaning as per the procedures.
4. Area cleaning and maintaining the state of clean-rooms Class-A, B, C, D and Unclassified areas.
5. To operate and clean the equipment, instrument or accessories used during the routine production activities as per the SOP.
6. To perform operations related Machine parts cleaning as per the production plan and as per the Instruction of Supervisor/Designee.
7. To perform operations related to autoclave unloading and aseptic Handling of Sterilized Items as per the production plan and requirement.
8. Machine parts Assembling in the filling line and filling operations during the media fill and batch production process in the class – B Area.
9. To adhere with the cGMP principles and follow the Standard Operating Procedure as defined.
10. Data Integrity within work environment without fail as per the defined procedure.
11. Handle waste and rejects as per procedure
12. To assist in other unit operations as and when required or as instructed by the Supervisor/Manager

Core Competencies:

1. Disciplined, Open for new learnings at the workplace.
2. Good on Process Compliance & implementation skills.
3. Basic command in English.
4. Responsible in approach, high on Accountability & Ownership.
5. Strong understanding and practice of ‘cost consciousness’.
6. Good in Time & Task Management.

Qualification/Functional Knowledge:

1. Diploma/Degree in science/Chemical Engineering/Pharmacy.
2. Functional knowledge of pharmaceutical industry, understand the operation process.
3. Knowledge with cGMP principles