Junior Team Member

1 week ago

India Cipla Full time

Job Description Division Department Sub Department 1 Job Purpose To execute the activities that are related to microbiology laboratory. Key Accountabilities (1/6) I. Involvement in all quality related activities. - Maintenance of all the area and the equipment. - To ensure and monitor compliance with GLP and cGMP as per requirements of the respective authority. Key Accountabilities (2/6) II. Environment monitoring - Monitoring of area to be carried out as per allocated schedule. - Release and transfer within the timeframe mentioned in SOP. - Follow the written procedure for Execution of aseptic process validation and testing of Aseptic process validation sample. - Involvement in process Simulation. Key Accountabilities (3/6) III. Media, PST management - Stock of media and presterilized items to be maintained. - Issuance to be done as per requirement Key Accountabilities (4/6) IV. Water and MLT - Water Analysis to be carried out as per schedule - MLT to be carried out as per planning. - Pathogen Continuation and releases should be on time - Should ensure completeness of entries of all the tests performed and compilation of relevant data before submission for review. - Disposal of balance samples after completion of analysis and review Key Accountabilities (5/6) V. Training - To be present in any arranged scheduled training by the trainer. - LMS training to be caried out before due date. Key Accountabilities (6/6) Major Challenges - Releases of all the activities carried out should be on time. - Maintenance of stock in the laboratory. - Decontamination of material should be on time. Key Interactions (1/2) I. Internal - Interaction with team members for all related activities including handover during shift changeover. Key Interactions (2/2) II. External - Interaction with service engineers during AMC and laboratory visits. - Interaction with external party during external calibration and validation of equipment. Dimensions (1/2) Should have basic knowledge of microbiology and relevantly qualified. Dimensions (2/2) Key Decisions (1/2) Decisions - Suggestions and ideas for work simplification. - Connecting with external Subject Matter Experts/ senior leaders within Cipla. Key Decisions (2/2) Education Qualification Educational Qualifications - Post Graduate in Microbiology Relevant Work Experience Relevant experience: - 2 - 5 years in pharma, microbiology. - Good Knowledge about pharma process 2-5 years (Quality section) - Good knowledge about computer (Excel, PPT and word file)

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