Desired Profile Job Accountabilities:
• Conducts duties following established Apotex Research Pvt. Ltd., Bioequivalence Centre’s, Standard Operating Procedures and in a consistent manner consistent with current regulatory (TPP, USFDA, TGA, ICH…etc…) guidelines / established practices / expectations.
• Performs bioanalytical method development and validation for the quantification of drugs and metabolites.
• Operates general laboratory equipment and instrumentation systems and utilizes automated data collection/reporting systems.
• Sets-up and ensures calibration of analytical systems and maintains instrument systems in good working order.
• Documents all the work and results of all assignments as required.
• Assists in the preparation of lab reports.
• Investigates and corrects analytical, instrumental, and procedural problems, if necessary in consultation with supervisor or management.
• To receive the plasma samples from the clinic and ensure their proper storage until further assay
• To write and revise SOPs as per need and maintain awareness of and adherence to all current SOPs.
• To over see the raw data compilation and their archiving after completion of final reports.
• Performs routine maintenance on Mass Spectrometers and associated HPLC equipment.
• Applies assay for the routine batch analysis of drugs and metabolites in biological fluids involving simple to complex analytical techniques.
Performs additional related duties as assigned by Management.
• Should have minimum 3 to 5yrs experience in BA/ BE studies not in DMPK studies.
• Should have knowledge on method development, validation, sample analysis, LC-MSMS techniques and regulatory updates.
Experience 3 - 6 Years
Education UG - B.Pharma - Pharmacy
M.Pharma - Pharmacy
Contact Saikat Sen
send resumes to: careers@apotex.co.in
Website http://www.apotex.com