Production Operator - Sterile Filling

GUFIC BIOSCIENCES LIMITED; Indore District, Pithampur; On-site; INR 180,000 - 240,000; Full time

Job summary

GUFIC BIOSCIENCES LIMITED is seeking a filling operator for its sterile injectable plant in Indore. The role involves operating and maintaining ampoule filling machines, ensuring aseptic processing, and strictly following cGMP and SOPs.

The ideal candidate has hands-on experience in aseptic filling, adherence to safety rules, and the ability to coordinate with QA/QC, engineering and other departments to ensure smooth day-to-day operations.

Qualifications

• Experience as a filling operator in pharmaceutical aseptic filling is required.

Responsibilities

• Follow safety rules per company norms.
• Operate and maintain Ampoule Filling machines and other filling area equipment.
• Monitor DP, RH and temperature in aseptic area.
• Maintain BMRs and log books per cGMP & SOP.
• Operate and clean area equipment in filling area.
• Perform in-process checks during filling.
• Clean aseptic area and coordinate with engineering as scheduled.
• Operate/clean all aseptic area equipment; change parts; storage per procedures.
• Perform environmental monitoring of viable aseptic area.
• Coordinate with QA, QC, Warehouse, Engineering, HR, Admin for daily activities.
• Ensure timely calibrations and validations with engineering and QA for aseptic area.
• Complete cleaning verification and prep filling parts for autoclaving.
• Complete SOP training and on-the-job trainings for aseptic area.
• Operate/clean CIP/SIP for vessels before/after batch processing.
• Perform other duties as directed by HOD.

Skills

Ampoule filling

Equipment maintenance

C GMP compliance

Environmental monitoring

BMR documentation

Aseptic processing

QA coordination

Tools

CIP/SIP systems

Autoclave

Job description

Role & responsibilities

1. To follow safety rules in the premises according to the company norms.
2. Responsible for operation and maintenance of Ampoule Filling machine & other equipment's of filling area of Pharma Sterile Injectable Plant.
3. Monitoring of DP, RH and temperature in aseptic processing area.
4. To maintain the BMRs and other log books in the aseptic processing area as per cGMP and SOP.
5. Responsible for operation and cleaning of area equipment present in the filling area
6. Responsible to perform the in process checks during filling.
7. To perform aseptic area cleaning and coordinating with engineering department as per the schedule.
8. Operation and cleaning of all Aseptic area equipment, change parts and storage as per the procedure.
9. Responsible for environmental monitoring of (Viable) aseptic processing area.
10. Responsible for the co-ordination with cross functional departments like QA, QC, warehouse Engineering, HR and administration for day to day activities.
11. Responsible for timely completion of calibrations and validations in coordination with engineering and QA related to aseptic processing area.
12. Responsible for cleaning verification and preparation of filling parts for autoclaving.
13. Timely completion of SOPs training and on the job trainings related to aseptic processing area.
14. Operation and cleaning of all equipment's like CIP / SIP for vessels before starting of the batch process and after completion of the batch process related to filling and filtration.
15. Activities other than defined in the job responsibility are to be done, as per the requirement of HOD, by following HODs instructions and guidance

Preferred candidate profile

Previous working experience as Filling operator is must