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| Job Location | Ahmedabad |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Pharma / Biotech |
| Functional Area | Sales / BD |
| EmploymentType | Full-time |
Bioanalytical Monitor Ahmedabad1+ Years 2 Positions AhmedabadOnline and retrospective monitoring of Bio- analytical phase of clinical studiesReview of standard operating procedures, standard testing procedures and executed documentsInvolved in the review of all executed study documents for completeness and clarity.Involved in the review of study raw data, Final cross table, Accountability, repeats, ISR for accuracy and adequacy.Review of Bioanalytical Method Development, validation reports and study reportsReview of SOPS for adequacy and compliance with GCP/ GLP and method SOPs that define a set of specific direction that must be followed during analysis of biological samples as per regulatory requirements.Communication with Bioanalytical team to take response of QA observation.Ensure that each event is conducted and documented properly as per the SOPs and protocol is followed.Complete documentation review in case of deviation, note to file, memo to file, amendments, errata, change control etc.Responsible for periodic checking of calibration and preventive maintenance of all instruments in Bio- analytical laboratory.Actively involved in the SOP drafting and revision of SOPArchival of generated data at PharmaZonePeriodic self- evaluation and trainingProvide conduction to new joiner and to train them on the Pharmazone systemMonitoring report preparationPreparation of observation bank for reference and usePeriodic update in regulatory guideline and circulate within teamTo watch over recent trends in CRO and queries from regulatoryTo evaluate methods available in different CROsReview of Pharmacokinetic raw data and statistical analysis of study and to check completeness of PK report as per guideline and sponsor requirements. data- experience 1+ Years,
Keyskills :
standardoperatingprocedures changecontrol methoddevelopment ts statisticalanalysis preventivemaintenance qa pk cro isr glp sop set testing control repeats analysis drafting clinical protocol alidationrep