Executive

5 - 10 years

7.0 - 12.0 Lacs P.A.

Pune

Posted:2 weeks ago| Platform: Naukri logo

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Skills Required

Equipment qualificationSAPMicrobiologyEHS managementBankingProcess excellenceGMPRaw materialEnvironmental monitoringSTP

Work Mode

Work from Office

Job Type

Full Time

Job Description

To perform and Bioburden test for water, raw material, and Product. Media Preparation required for utility and area monitoring. Sub Culturing, serial dilution of standard cultures and GPT. Environmental Monitoring of all classified areas Operation of decontamination autoclave. To perform SAP and LIMS related transactions as per authorization. To perform Submission and request of records on Doc cell. Preparation and review of Microbiology related SOP s/STP s/Validation protocol and Report. To initiate Change control, Deviation and CAPA related to Microbiology as per QAMS authorization. To monitor temperature data of incubators in Lisaline. To ensure online documentation as per GMP requirement. To perform sterility Testing of RM, PM and Product. To perform Cell bank testing. To perform stability aliquoting To comply with the current & subsequent EHS management system, procedures, guidelines, policy, practices, requirements, and applicable legal compliances on site. Preparation of Microbial Library for in house isolate identified from water and environmental monitoring samples. To perform cell banking system. Daily pH, Balance Calibration and Temperature recording. Cleaning and disinfection of the controlled areas. Sink cleaning. Equipment qualification IQ/OQ/PQ/RQ and PV) / calibration activities related to Microbiology dept. Any other responsibility advised by the superiors from time to time. Work Experience 05 Years of relevant experience Education Masters in Microbiology or Biopharmaceutics Post Graduation in Microbiology Competencies 2. Innovation & Creativity 3. Customer Centricity 5. Result Orientation 6. Process Excellence 7. Collaboration

Pharmaceuticals
Pune

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