Technical Assistant
Job Description
. Responsible for operating vial/bottle and ampoule washing, filling and capping machine and PFS filling Machine at Dholka premises.• Should have knowledge of Operating and maintenance of vial/bottle filling, Washing and capping m/c, Depyrogenation tunnel, Labeling Machine.
• To do aseptic and processing area entry exit procedure properly with proper gowning.
• Should have knowledge of working in aseptic and processing area.
• Repair and maintenance of all machines of parenteral manufacturing area.
• To check and ensure that differential pressure and Temperature of the aseptic area and processing area are within limit and record it properly.
• To check and ensure that pressure differential of all Laminar Air Flow are within limit and record it properly.
• To check on line in process parameters like temperature, RH, DP, fill volume, quality of sealing at specific interval as mentioned in respective MMDI and SOPs.
• To ensure proper inter personal relationships (IPR) in the section.
• To ensure proper cleaning of the working areas.
• To ensure proper status labeling as per Sop.
• To ensure the all required documents to comply cGMP.
• Reporting to Shift In charge for routine activities & special assignment given by seniors. Submit reports on performance and progress
• To ensure calibration certificates of all measuring instruments comply with norms.
• To review daily production and to discuss other issues.
• Responsible for operating of washing, filling and capping machine of vial, bottle and ampoule and PFS filling Machine at Dholka premises.
• Should have knowledge of operating and maintenance of filling, washing and capping m/c, Depyrogenation tunnel, Labelling Machine.
• To do aseptic and processing area entry exit procedure properly with proper gowning and sanitization.
• Should have knowledge of working in aseptic and processing area.
• Repair and to do maintenance of all machines of parenteral manufacturing area.
• To check and ensure that differential pressure and Temperature of the aseptic area and processing area are within limit and record it properly.
• To check and ensure that differential pressure of all Laminar Air Flow are within limit and record it properly.
• To check on line in process parameters like temperature, RH, DP, fill volume, quality of sealing at specific interval as mentioned in respective MMDI and SOPs.
• To ensure proper inter personal relationships (IPR) in the section.
• To ensure proper cleaning of the working areas.
• To ensure proper status labeling as per Sop.
• To ensure the all required documents to comply cGMP.
• Reporting to Shift In charge for routine activities & special assignment given by seniors. Submit reports on performance and progress
• To ensure calibration certificates of all measuring instruments comply with norms.
• To review daily production and to discuss other issues.