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

Cipla

  • Rangpo, Sikkim
  • Permanent
  • Full-time
  • 9 days ago
DivisionDepartmentSub Department 1Job PurposeTo 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 QualificationEducational qualifications:
  • Post Graduate in Microbiology
Relevant Work ExperienceRelevant 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)

Cipla