Basha Kanala

Site Lead - Product Quality and Regulatory Compliance

Role
Site Lead - Quality and Compliance at Biocon Biologics
Location
Hyderabad, TG, IN
LinkedIn followers
500 followers

About Basha Kanala

Accomplished Quality Control Leader, having 21 years of experience in Biologics and…

Experience

  1. Site Lead - Quality and Compliance

    Biocon Biologics

    May 2023 — Present · Bengaluru, IN

    Leading the Site Quality Control team, responsible for working closely with cross functional senior leadership and establishing and maintaining Quality system to assure the overall Lab compliance.Batch Release: Management of overall testing and timely release of batchesHarmonization: Ensure compliance through harmonization of procedures and analytical technology for methods, specifications, stability procedures and method validation elements.Documentation: Approval of Analytical method validation protocols, reports, SOPs, STPs, in process/finished product specifications and LIMS activities.QMS: Collaborating effectively with QA representatives to manage the initiation, investigation, and closure of discrepancies, Incidents, LIRs, OOS, OOT, Quality Risk assessment and deviations.Audit: Organize internal audits and external audits. Review of audit compliance reports and ensure closing of all observations through effective CAPA.Develop and deliver training programs for staff across functions & all levels.Involving with various internal stakeholders inside the QC, QA and Regulatory affairs to streamline processes across the organization and implement improvements.Representing the QC departmental goals, strategies and budget proposals to the Top Management.Participate in monthly QC meetings to provide updates on QC accomplishments & Challenges.

Education

  • Sri Krishna Devaraya University

    Biochemistry

    2002 — 2004

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Basha Kanala — Site Lead - Quality and Compliance at Biocon Biologics in Hyderabad, TG, IN | Unifers