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Sr Assoc, Microbiology

2.00 to 5.00 Years   Ahmedabad   30 Nov, 2022
Baxter India
Job LocationAhmedabad
EducationNot Mentioned
SalaryNot Disclosed
IndustryManufacturing
Functional AreaBio Tech / R&D / Scientist
EmploymentTypeFull-time

Job Description

    Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.Join us at the intersection of saving and sustaining liveswhere your purpose accelerates our mission.Conducting routine analysis of raw materials, in-process, finished product samples & stability study samples for Different Microbiological Test as per Good Laboratory Practice (GLP).Performing the Environmental monitoring.Documentation as per the Pharmaceutical regulations of various regulatory authorities and Preparing documentation of the in-house developed Microbiological methods, study protocols, standard testing procedures, specifications & method of analysis for routine used by QC personnelCoordinating with QA / QC personnel for implementation of the current / revised standard testing procedures, specifications and method of analysis.Scientifically sound / technical Writing skill for audit response to different regulatory agency and having the knowledge of different regulatory guidelines.To provide the training to Microbiologist on laboratory technique, quality control procedure & principles of GMP/GLP, Data integrity policy.Experienced in external & internal audits and ensuring effective implementation of CAPA related to different regulatory observationConducting risk analysis for different microbiological processes.Knowledge of Quality Management System (Change control, Non-conformance, LIR, OOL etc.)Resourceful in Environmental Monitoring of clean room and contamination control strategy.Knowledge of microbiological Instrument/Equipment and Automated Microbiologic machines.Skilled in Track-wise system and in LIMS/MODA for the Environmental MonitoringSkill to build the inspection plans for various components proficiency in managing audits by US-FDA, ANVISA, EU-GMP, National GLP, MHRA and other Regulatory & Customer Audits.,

Keyskills :
QAQCLIR

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