Loading
X
Call Us Today! @ +91 9989923666
Lokeswara Kavali

Associate

About Lokeswara Kavali


Lokesh is an Associate in the GMP Compliance Practice at QualiCulture Consulting Group, who has over 10 years experience in sterile / aseptic production for bulk pharmaceuticals / finish dosage forms and biopharmaceuticals and Quality Assurance / Quality Control microbiology (sterility testing/ laboratory methods). He delivers efficient support and widespread expertise toward solving the challenges of aseptic processing / sterile production and QA/QC microbiology environment. He is technical architect in preparation of responses for FDA Form 483 inspectional observations, Warning Letter and other regulatory findings. He is expertise in developing remediation / corrective action plans for addressing the regulatory enforcement actions (import alert ,notice of concern, notice of suspension etc.).
EXPERTISE:        

  • Assist in the development of responses to FDA 483s, Warning Letters  and other regulatory findings
  • Perform GMP, Compliance and Quality Systems audits and CAPA management
  • Deliver Quality, Compliance, and Regulatory training
  • Perform technical writing (protocols, reports, specifications, policies, procedures)
  • Perform risk analyses of sterile and aseptic processing production systems; Incorporate risk assessment components and rationale
  • Deliver sterility assurance expertise; Troubleshoot sterility and compliance issues
  • Set up new media fill / environmental monitoring programs; Initiate upgrades of environmental monitoring, media fill and training / QA awareness programs for production operators
  • Conduct audits of Quality Systems to assure compliance with internal SOPs, standards and regulatory requirements
  • Perform quality reviews of sterilization and aseptic validation and revalidation protocols, including media fills
  • Conduct investigations into process deviations and problems, and determine appropriate corrective and preventive actions to prevent recurrences, including laboratory and positive sterility investigations
  • Compliance GAP Assessments, Regulatory Inspection preparation, remediation, floor compliance, mitigation of Quality Systems and manufacturing process GAPS, Non-Conformance Investigations, Batch Records Review, QA and Manufacturing Process data for metrics evaluation
  • Participate in US FDA, EU and other worldwide regulatory agency pharmaceutical inspections as subject matter expert; manage teams to support record / information requests during regulatory inspections

EXPERIENCE:    

  • Worked as Manager - Global Audits and Compliance at India's largest Pharmaceutical Company  
  • Worked at Hospira (now Pfizer Company), Biocon Ltd. and Aurobindo Pharma Ltd in various roles related to Quality Assurance and Microbiology.

EDUCATION:

  • Master of Science in Microbiology


View LinkedIn Profile