Production Operator - Sterile Filling

GUFIC BIOSCIENCES LIMITED; Indore District, Pithampur; On-site; INR 250,000 - 400,000; Full time

Job summary

GUFIC BIOSCIENCES LIMITED in Indore is hiring a filling operator to operate and maintain ampoule filling machines and related equipment in the Pharma Sterile Injectable Plant. You will monitor DP, RH and temperature in aseptic areas, maintain BMRs and logs per cGMP and SOP, and coordinate with QA, QC, Engineering, HR and admin for daily activities.

The role requires prior experience as a filling operator and the ability to perform in-process checks, aseptic cleaning, and equipment

Qualifications

• Previous working experience as Filling operator is must.

Responsibilities

• Follow safety rules and company norms in the premises.
• Operate and maintain Ampoule Filling machine and other equipment in the filling area of the Pharma Sterile Injectable Plant.
• Monitor DP, RH and temperature in aseptic processing area.
• Maintain BMRs and log books in aseptic processing area per cGMP and SOP.
• Operate and clean area equipment in the filling area.
• Perform in-process checks during filling.
• Clean aseptic area and coordinate with engineering as per schedule.
• Operate and clean all aseptic area equipment, change parts and storage per procedure.
• Environmental monitoring of viable aseptic processing area.
• Coordinate with QA, QC, warehouse, Engineering, HR and admin for day-to-day activities.
• Ensure timely completion of calibrations and validations with engineering and QA.
• Complete cleaning verification and prepare filling parts for autoclaving.
• Complete SOPs training and on-the-job trainings related to aseptic processing area.
• Operate and clean CIP/SIP for vessels before and after batch processing related to filling and filtration.
• Undertake other tasks as instructed by HOD.

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