Bhaskar Reddy

Background

About Bhaskar Reddy

Have Over 20 Years of experience in sterile Pharmaceutical Companies. Have experience in Handling of Regulatory inspections USFDA, ANVISA, EMEA, National Agency for Medicines (NAM- Finland), WHO audits. Harmonization of procedures and practices:• Draft / review / update Policies, Procedures related to Validations and Sterile Assurance.• Harmonize the Procedures related to Validations and Sterile Assurance across all units2. Improving breadth and depth of Knowledge:• Identify and lead a network of Validations / Sterile Assurance Subject Matter Experts.• Act as a Trainer for Validations and Sterile Assurance related Training programs.3. Investigations and CAPA:• Act as CAPA coordinator for the CAPA related to Validations and Sterile Assurance.• Part of Investigations Team for Validations and Sterile related Investigations.• Act as Cross Functional Reviewer for Validations and Sterile Assurance related changes, Non conformances, OOS etc, wherever applicable.4. Act as Internal Auditor for Validations and Sterile Assurance area, wherever required.5. Proactively assess risk, plan and execute audit deliverables. Work with sites to ensure their sterility assurance systems are properly prepared for external and internal compliance inspections.6. Qualification of new facilities for sterile formulations as per current regulatory standards.7. Hands on experience( in new emerging technologies) for qualification of different kinds of manufacturing process lines such as:• Vial filling Line.• Vial filling Line with Lyophilizer.• Ampoule filling Line.• Vial / Ampoule filling Line (Combi Line).• PFS (Pre Filled Syringes) Line.• 3 Piece ophthalmic Line.• BFS (Blow Fill Seal) Line.• FFS (Form Fill Seal) Line.• Aseptic formulation / Terminal sterilization.8. Escalate Validations and Sterile Assurance related issues to Senior Management.