Officer - Quality Control

Lupin

1 - 4 years

4 - 5 Lacs

Pune

Posted:1 week ago| Platform:

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Skills Required

Water testing Biotechnology SAP Microbiology Compliance GMP Management Environmental monitoring Monitoring

Work Mode

Work from Office

Job Type

Full Time

Job Description

Daily Monitoring and Calibration: Perform daily pH, balance calibration, and temperature recording. Monitor temperature data of incubators in Lisa line.
Cleaning and Disinfection: Clean and disinfect controlled areas.
Sampling and Analysis: Perform compressed air sampling and analysis. Conduct water sampling, water testing, and water continuation. Perform bioburden, BET tests for water, raw materials (RM), and products. Conduct sterility testing.
Environmental Monitoring: Perform environmental monitoring and prepare EM trends. Prepare a microbial library for in-house isolates identified from water and environmental monitoring samples.
Microbiological Procedures: Subculture, perform serial dilution of standard cultures, and conduct CPT. Incubate exposed biological indicators (BI) in autoclave validation and report results. Perform population determination of biological indicators.
Documentation and Compliance: Ensure online documentation as per GMP requirements. Prepare and review Microbiology-related SOPs, STPs, validation protocols, and reports. Perform transactions in SAP and QAMS as per authorization. Perform activities as per the authorities provided for LIMS.
Change Control, Deviation, and CAPA: Initiate and manage Change Control, Deviation, and Corrective and Preventive Actions (CAPA).

Work Experience

1 to 4 year

Education

Masters in Microbiology or Biotechnology

Competencies

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