CH Suresh Babu

  • Assistant Manager - Quality Assurance
  • Pedhavegi
  • Nov 01, 2019
Full time Research

Personal Summary

  • Detailed oriented professional with competent experience of 10+ years with key focus on Quality Control, Quality Assurance, and Audit management, Documentation in Biotechnology, Pharmaceuticals, and Research Industry
  • Actively involved in liaising with Medical Affairs (MA), Regulatory Affairs (RA), Research & Development (R&D) and/or Toxicology to ensure gathering and assessment of the safety information is appropriate for the assigned task for PDC group in the organization
  • Hands-on experience in planning internal audits within the department, closing of the audit points raised by the regulatory agencies/internal audits, performing external audits & method transfer for QC and preparation of audit reports
  • Extensive experience in Health Canada US FDA, EDQM, MHRA, TGA and customer audits
  • Assisting with developing proposals for clients and assist with management, upholding current knowledge of PK and PK/PD science, GCP and ICH guidelines, regulatory guidance documents, FDA rulings, internal SOPs, and internal working practices and established sound knowledge on various clinical systems, processes and project management activities
  • Effectively coordinating managing high level timelines with inputs from functional departments, project teams and clients also following-up on critical action items and alert project team of potential roadblocks or delays
  • Efficient and effective time management skills, adhering to turn around time and extremely composed under pressure with an ability to adapt to diverse situations with ease and deliver results
  • Well-developed organizational skills with success in managing multiple activities, along with leadership, analytical and problem-solving abilities

Work Experience

Assistant Manager - Quality Assurance
Dec 2015 - Nov 2019 Dr.Reddy’s Laboratories Limited
  • Detailed oriented professional with competent experience of 10+ years with key focus on Quality Control, Quality Assurance, and Audit management, Documentation in Biotechnology, Pharmaceuticals, and Research Industry
  • Actively involved in liaising with Medical Affairs (MA), Regulatory Affairs (RA), Research & Development (R&D) and/or Toxicology to ensure gathering and assessment of the safety information is appropriate for the assigned task for PDC group in the organization
  • Hands-on experience in planning internal audits within the department, closing of the audit points raised by the regulatory agencies/internal audits, performing external audits & method transfer for QC and preparation of audit reports
  • Extensive experience in Health Canada US FDA, EDQM, MHRA, TGA and customer audits
  • Assisting with developing proposals for clients and assist with management, upholding current knowledge of PK and PK/PD science, GCP and ICH guidelines, regulatory guidance documents, FDA rulings, internal SOPs, and internal working practices and established sound knowledge on various clinical systems, processes and project management activities
  • Effectively coordinating managing high level timelines with inputs from functional departments, project teams and clients also following-up on critical action items and alert project team of potential roadblocks or delays
  • Efficient and effective time management skills, adhering to turn around time and extremely composed under pressure with an ability to adapt to diverse situations with ease and deliver results
  • Well-developed organizational skills with success in managing multiple activities, along with leadership, analytical and problem-solving abilities
Jr Manager – Quality Control
Dec 2012 - Dec 2015 Dr.Reddy’s Laboratories Limited
Chemist – Quality Control
Jun 2008 - Dec 2011 Dr.Reddy’s Laboratories Limited

Education

Bachelor of Science
Mar 2001 - Mar 2004 Andhra University