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

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)