Bioanalytical Researcher
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Responsible for development and validation of bioanalytical methods and analyzing the study samples using LCMS/MS, ICP-MS and HPLC in accordance with regulatory guidelines, sponsors requirements and applicable principles of GLP.
To perform QC check for bioanalytical activities.
Preparation of bioanalytical methods & bioanalytical protocols.
Preparation and review of departmental and related SOPs in compliance with regulatory guidelines and applicable principles of GLP requirements.
Calibration of instruments/ equipment in co-ordination with instrumentation engineer/service engineer.
To review study protocols and provide bioanalytical inputs.
To review MD data, Pre-MV reports, MV reports, bioanalytical reports.
To review raw data forms, log books for entries as per departmental SOPs.
Preparation of Bioanalytical reports and Method validation reports
Preparation of reagents, solutions and weighing of working standards, as required.
To impart trainings to bioanalytical personnel on departmental SOPs / regulatory guidelines.
Calibration / performance check of testing equipments.
To prepare and be present for audits / regulatory inspections
Archiving all files related to method validation and biostudy.
Experience in development and validation of bioanalytical methods and analyzing the study samples using LCMS/MS, ICP-MS
HPLC in accordance with regulatory guidelines, sponsors requirements and applicable principles of GLP.
Address: 303-B, Main St, Hiranandani Gardens, Sainath Nagar, Powai, Mumbai, Maharashtra 400076
Email: [email protected]