01 Nov
|
Veeda Lifesciences
|
Bengaluru
01 Nov
Veeda Lifesciences
Bengaluru
Experience Required: 12 to 15 Years
Location: Peenya, Bangalore
Job Responsibilities
MD / MV and Study handling:
Acts as an Analytical Project Manager for GCLP studies as delegated by TFM/Deputy TFM.
Ensure and guide the team for method development and method validation using ligand binding assays, cell-based assays and LC-MS/MS based assays and study related activities.
Review of raw data, unforeseen events, file notes and deviation.
Strategize and plan MD/MV and study sample analysis efficiently and deliver the projects within the defined timelines.
Inventory management
Ensure timely procurement of chemicals/reagents/consumables and maintaining inventory for MD/MV and study sample analysis related activities.
Preparation / Review of documents
Responsible for preparation/review of current Policies, SOPs, Protocols, Plans/STPs/Reports/Lab manuals and their implementation.
QC/QA and regulatory related
Reply to relevant QC and QA queries in co-ordination with team members and QC respectively.
Responsible for study audit from sponsor.
Responsible for the compliance to relevant audit & regulatory/sponsor findings.
Equipment / Software related
Review of IQ/OQ/PQ, calibration and maintenance documents of equipment/software.
Ensure timely Calibration/ Maintenance / PM of equipment.
Review of Audit trails based on the requirement.
📌 Group Lead Bioanalytical Bengaluru
🏢 Veeda Lifesciences
📍 Bengaluru