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Junior Team Member - Internal Audits / QA / QC / Sterile / Microbiology

Junior Team Member - Internal Audits / QA / QC / Sterile / Microbiology

ConfidentialIndia
12 days ago
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)
  • Skills Required

    Word, Cgmp, Microbiology, Excel, Glp, Water Analysis

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    Audit Team Member • India

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