Quality Analyst I

Job description Responsible for stability sample management and its related documentation. Prepares and Reviews stability protocols and Study Reports. Responsible for chamber management and its related documentation. Execution, review the stability equipment, IT system maintainace activities related to preventive maintainace, Alarm Hooter Challenges, Annual Maintainace, Periodic verification, performance evaluation, and qualification activities are performed as per approved procedures. Responsible for Release of Analytical Reports and Study scheduling in SAP R/3 System. Responsible for introduction and execution of new stability equipment, changes to equipment and equipment qualification and validation activities. Responsible for Co-ordination with inter-department and RnD for all related and submission with respect to Hold Time Study and Stability. Responsible for Coordination and review of master batch records, (validation, exhibit, trail, commercial, intended, ANDA), protocols and reports (validation, summary reports, packaging, ANDA and general study protocol and reports). Responsible for execution of SAP activities BOM review and approvals Responsible for preparation and review of related SOP s. Responsible for investigation related to the assigned areas. Key Job Roles: Hold Time, Stability Study Activities and Review of Master Batch Records