Production Officer/Sr. Officer/Executive (Injectable) | Gufic Group | Navsari

Job Description

Roles and Responsibilities:

• Follow the instructions & procedure given in the Entry-Exit SOP (Standard Operating Procedure) of Grade C, De-cartooning area, and Grade ‘B’ area.
• Responsible for a procedure for proper functioning or behavior in an aseptic area.
• Follow the personnel hygiene practices on factory premises.
• Follow the GMP (Good Manufacturing Practices) and GDP (Good Documentation Practices) as per given in the SOP.
• Responsible for monitoring temperature, relative humidity, and differential pressure.
• Responsible for monitoring of differential pressure of laminar airflow units and pass boxes.
• Responsible for handling material movement in the production area.
• Responsible for maintaining the document as per GDP and area as per cGMP.
• Responsible for maintaining day-to-day records.
• Responsible for training new chemists, workers, and operators for their respective jobs.
• Carrying out the line clearance before starting the operation.
• Responsible for planning of manufacturing as per availability of RM and PM.
• Responsible for supervision of preparation and filtration of cleaning/ disinfectant solutions and fogging solutions.
• Responsible for supervision of equipment/ machines and utility readiness before batch manufacturing.
• Responsible for supervision of operation and cleaning of steam sterilizer, compounding vessel and holding vessel, vial washing machine, sterilization and depyrogenation tunnel, washing and drying, and wrapping of garments and pass box and laminar airflow.
• Responsible for supervision of handling of filters, filter integrity testing apparatus, silicon tubing, decartoning area, and hose pipes and cleaning and wrapping of glassware, auxiliary items, and machine parts.
• Responsible for supervision of the operation of pH meter and stirrer.
• Responsible for supervision of aseptic process stimulation, post-media fill cleaning, and sanitization of machine and area as per procedure.
• Responsible for the destruction of media-filled vials.
• Responsible for supervision for general area cleaning and sanitization of grade ‘C’ and ‘D’ area and fogging activity of respective area.
• Responsible for verification of load cell.
• Responsible for verifying the handling of waste generated in the production area.
• Responsible for nonviable particle count (online and offline) monitoring.
• Recording the operation and cleaning details in batch manufacturing records and equipment uses a log book.
• Responsible for handling of equipment like homogenizer, rota evaporator, magnetic stirrer, ultrasonication, pH meter, and fogger.
• Follow the procedure for the dispensing room and be responsible for RM and PPM dispensing and additional materials issuance.
• Responsible for all data entry for the batch manufacturing process in Pharmacloud system.
• Responsible for audit preparation and execution.
• To undergo periodic medical checkups arranged by the company.
• Performing the task assigned by the supervisor.
• Reporting regarding unsafe act/ unsafe conditions/accidents/incidents to supervisors.
• Any other responsibilities assigned by the HOD

Desired Candidate Profile

• Candidate Should have Exposure of Pharma Injectable Plant.
• Candidate Should well familiar with Pharma Guidelines.
• Candidate should have good Verbal and Written Communication
• Willing to Relocate in Navsari, Gujarat,
• Willing to Work in a Shift.

Qualification: B.Pharma, M.Pharma, MS/M.Sc(Science)