Title:  Officer Quality (Micro)

JOB DESCRIPTION

Designation: Sr. Officer

Department: Microbiology

Years of Experience: 3-6 Years

Education Qualification: Msc or BPharma

Responsibilities

:        Ensure compliance to cGMP and safety standards in the Microbiology Lab.

:        Ensue and Participate in media fill activities and its analysis like pH & GPT of media fill samples, incubation and observation of media fill vials/plates.

:        Ensure for Nitrogen & Compressed air sampling and analysis.

:        Ensure to Clearance for processing, in process checks and process monitoring in the aseptic processing area.

:        Ensure Identification of Microorganisms and Culture Management.

:        Ensure environmental monitoring of Microbiology Laboratory.

:        Ensure timely prepare Monthly trends, Quarterly summary and annual summary reports of Environmental monitoring.

:        Ensure timely preparation and Review of Validation protocols/reports and other quality documents.

:        Assist with reporting and verification of test results/reports.

:        Ensure to maintain All time readiness (ATR) for the activities performed in Shop floor (pertaining to environmental monitoring) and Microbiology Laboratory.

:        Evaluate and ensure analytical data and calculation of results.

:        Ensure integrity, accuracy and adequacy of the analysis performed.

:        Provide microbiological support in plant validation & qualification activities.

:       Ensure compliance to cGMP and safety standards in the Microbiology Lab.

:       Conduct microbiological analysis of raw materials, in-process samples and finished

        Products, PM and Stability.

:       Document analytical data and calculate results.

:       Conduct Analytical Method validation of products.