Analytical Researcher I
Ambernath, India, 421506
Who we are
How you’ll spend your day
- Shall have FDA approval in Microbiology
- To carry out Microbiological testing of various products like in-process, finished products, pre-formulation study samples and stability samples etc.
- Check analytical results and suggest further course of action.
- To carry out Microbial method development, method validation and transfer activity.
- Preparation and updating of STP and analytical related SOPs.
- Regulated market experience (US/EU/Canada etc)
- Laboratory resources management.
- To execute Microbial method validation as per the protocol and to complete the required documentation.
- Calibration and maintenance of analytical instruments. Maintenance includes activities such as Qualification, keeping track of AMC, History, Spares, Usage records etc.
- To ensure that all activities undertaken are executed in the framework of good laboratory and documentation practices and the existing quality systems are adhered to.
- To ensure safe practices are followed during the execution of activities and strict adherence to the EHS systems of the site.
- Any other activity assigned by the line manager.
Your experience and qualifications
- M.Sc. / M. Pharm in Microbiology
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Overall Pharma industry experience: 4 plus years
- Sound knowledge of Microbiology and Microbial analysis, Microbial method development and method validation. Microbiological testing of various products like in-process, finished products, pre-formulation study samples and stability samples etc.
- Regulated market experience (US/EU/Canada)
- FDA approval in Microbiology.
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