Monic Inbaraj — CEO

P R O FI LE Head Bio-analytical department of Quantys clinical private limited (A Rusan pharma company); Responsible for overall operation and administration of a bioanalytical laboratory, including compliance with regulatory standards. Holding Master degree in pharmacy with over 16 years of experience in the pharmaceutical industry and Clinical Research Organizations supporting bioanalysis in clinical studies. R O L E S & R E S P O N S I B I L I T I E S o Directs and manages the activities of Bioanalytical staff. o Responsible for oversight and maintenance of study timelines and activities. This includes ensuring appropriate resources are available and scheduling of instrumentation is optimized. o Scientific oversight of bioanalytical method development and validation; serve as a scientific resource to the team of bioanalytical scientists to troubleshoot and innovate clinical methods. o Prepare, author and review bioanalytical sections for regulatory filings globally and provide timely responses to regulatory queries. o Establishes laboratory procedures, documentation and processes compliant with GLP. o Ensures all operations are performed in accordance with released SOPs, quality control and safety requirements. o Works with Site Leadership to regularly review and assess the appropriateness of SOPs and amend where required. o Ensures laboratory procedures, methods and personnel produce high quality services through a combination of observation, data evaluation and a proficiency testing program. o Ensure proper training is imparted for all study and lab personnel before study initiation. Ensure validated method is in place before study sample analysis. o Investigates and corrects analytical, instrumental, and procedural problems, if necessary in consultation with supervisor. o Participates in the human resource management functions including hiring, orientation and training, and performance evaluations of laboratory personnel. o Coordinates, along with laboratory manager, daily operations of the laboratory, including testing and personnel schedules. o Plan/oversee budgets and resources to ensure alignment with project and corporate goals and objectives. o Responsible for tracking and maintaining metrics governing the activities within the laboratory and reporting these to the Site Head on a regular basis.

Stackforce AI infers this person is a leader in the pharmaceutical bioanalysis sector with extensive regulatory expertise.

Location: Gujarat, India

Experience: 17 yrs