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 requirementKey Accountabilities (4 / 6)
IV. Water and MLT
Water Analysis to be carried out as per scheduleMLT to be carried out as per planning.Pathogen Continuation and releases should be on timeShould 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 reviewKey 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 MicrobiologyRelevant 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)Skills Required
Word, Cgmp, Microbiology, Excel, Glp, Water Analysis