Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Sr. Executive, Production
Job Description :
• To ensure the cleanliness of various areas like autoclave area, pre-sterilization area, post sterilization area, sterilizers and if any deviation is found, document and escalate the point, get it corrected immediately in coordination of production Sub-Department Manager and QA Sub-Department Manager as per defined SOP, and then start the further process.
• To ensure cleaning and sterilization of disinfectant preparation and filtration requirements is done as per SOPs
• To ensure that component(s) and product(s) are sterilized as per validated parameters.
• To ensure the availability of sterilized clean room garments and goggles.
• To supervise the behavior of workers at product loading & unloading site and during handling stages of sterilizer trolleys
• To check the online rejection(s), escalate and take immediate corrective action to minimize it in coordination of Production Manager and QA Manager.
• To ensure not to start the sterilization process if found any abnormality in sterilizer. Raise Work Request and ensure corrective and preventive actions are defined and implemented.
• To ensure not to start next cycle of Sterilization without rectification of problem, in case of any abnormality observed in printer, recorder, temperature, pressure and utility supply during the sterilization of any product.
• To check the equipment after preventive maintenance and if found any abnormality; ensure not to start further process.
• To record all the activities in the approved formats at the time of observation/activity is performed.
• To have thorough knowledge of SOP of own working area and ensure to practice it.
• To follow clean room behaviors strictly.
• Ensure that the PM, calibration and validation of equipment/system/facility is completed as per approved schedule.
• Ensure the housekeeping of the area is in controlled state.
• Ensure all safety norms are followed in respective area.
• Keep self and team updated about CGMP requirement.
• Ensure completion of all required training for self as well as team.
Candidate Profile : Diploma/ B. Pharma/ B.sc/ M.sc/BE with experience of 2 to 6 years from injectable production sterilization of disinfectant activity.
Job Description :
• To ensure the line clearance of packing before starting the packing of new batch in coordination with In Process Quality Assurance Chemist.
• To ensure the issue of material of the batch and taking the clearance from the In Process Quality Assurance Chemist, prior to schedule of respective product packing.
• To on line the updation in the packing records.
• To provide the data to transfer the packed goods to the finished goods store in coordination with Manager Manufacturing.
• To ensure the timely packing of unpacked goods from the General Quarantine area.
• To supervise the packing on line at frequent intervals as defined in the Standard Operating Procedure.
• To ensure the availability of packing material with proper labels and status.
• To do the reconciliation after completion of batch and submitting the data of the same.
• To keep the samples of each packing batch as per Quality Assurance and Quality Control requirement.
• To destroy the rejection generated during packing in presence of In Process Quality Assurance Chemist.
• To keep the status tags displayed properly so that the status of each material issued and packed is maintained as per the regulatory requirement and Standard Operating Procedure.
• To set and arrange the trained worker force according to norms to get the highest productivity and quality packing.
• To ensure the GMP norms are followed and maintained all throughout the packing.
• To train the work force for critical operations like visual inspection and labeling.
Qual. - M.Sc, B.Pharm
Experience - Between 3 to 7 years
Oper II, Production
Job Description :
• To monitor temperature or humidity of clean rooms and if any non-conformance found, inform the Engineering department.
• To ensure cleaning and disinfections of floor, ceiling, wall, pipeline, vessels and equipment as per frequency defined.
• To ensure cleanliness of airlocks after entry and exit of the workers.
• To maintain the cleaning and lubrication of machine regularly.
• To ensure the machine is working smoothly and it is performing well.
• To check the equipment after preventive maintenance and if found any dissatisfaction; ensure not to start further process.
• To expose settle plate under Filling LAF of Manufacturing Line as per defined frequency.
• To follow SOP and guide others also to follow the same.
• To ensure that the preventive maintenance of machine is performed regularly and timely.
• To maintain the machine in good condition by regular cleaning and lubrication.
• To report to Technical Department regarding any kind of maintenance work of clean room through work request form and inform to Sub Department Manager.
• To ensure proper gowning of personnel working in clean room.
• To ensure follow up of Standard Operating Procedure (SOP) during entry / exit from clean room.
• To ensure cleaning and steaming process is carried out as per validated procedure.
• To do the replacement of change parts and trial of machine within the time limit.
• To record the volume data in specified intervals, and if any abnormality is found, rectify immediately and inform to Sub Department Manager and Quality Assurance (QA) Department.
• To monitor the productivity continuously, if productivity is less than defined norms, take action immediately.
• Authorities for rejections or approval:
• To stop the machine immediately, if any quality related issue is found in the product, inform to Sub Department Manager – Production & OQ and rectify it with help from Technical Department.
• Communication to the management / superiors:
• To communicate any abnormality in product quality or machine operations to Technical Department and Sub-department Manager.
• To communicate any delay in startup or non- conformance from plan to Sub Department Manager.
• Must have 2 to 5 Years’ experience with injectable vial filling / Mixing activity
• Must have ITI Pass.
Additional Information :
Experience : 1 to 7 years
Qualification : M.Sc, B.Pharm, ITI
Location : Ahmedabad, Gujarat
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 15th July, 2022
Email CV to : [email protected]
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