Bhaskar Reddy Email

Bhaskar Reddy Skills

• Validation
• V&V
• Cleaning Validation
• Sop
• GLP
• Quality Assurance
• Validation Master Plans
• FDA
• CAPA
• . Draft / review / update Policies, Procedures related to Validations and Steri
• Identify and lead a network of Validations / Sterile Assurance Subject Matter E
• Formulation
• Harmonization of procedures and practices
• Improving breadth and depth of Knowledge
• Act as a Trainer for Validations and Sterile Assurance related Training pro
• Act as CAPA coordinator for the CAPA related to Validations and Sterile Assuranc
• Part of Investigations Team for Validations and Sterile related Investigations
• Act as Cross Functional Reviewer for Validations and Sterile Assurance rel
• Proactively assess risk, plan and execute audit deliverables. Work with sites to
• Escalate Validations and Sterile Assurance related issues to Senior Management.
• Act as Internal Auditor for Validations and Sterile Assurance area, wherever req
• Process validation
• FAT of processing equipments
• Standard Operating Procedure (SOP)
• Technology Transfer
• Corrective and Preventive Action (CAPA)
• Pharmaceutical Industry
• GMP
• Regulatory Affairs
• Good Laboratory Practice (GLP)
• U.S. Food and Drug Administration (FDA)
• Verification and Validation (V&V)
• Change Control
• Quality System
• U.S. Title 21 CFR Part 11 Regulation
• Regulatory Requirements
• For Validations and Sterile Assurance Rel
• Good Laboratory Practice Glp
• Trainer for Validations and Sterile Assurance Related Training Pro
• Verification and Validation V&V
• Draft
• Review
• Wherever Req
• Proactively Assess Risk
• Update Policies
• Procedures Related to Validations and Steri
• Corrective and Preventive Action Capa
• Identify and Lead a Network of Validations
• Sterile Assurance Subject Matter E
• u.s. Food and Drug Administration Fda
• Act as Internal Auditor for Validations and Sterile Assurance Area
• Act as Cross Functional Reviewer
• Standard Operating Procedure Sop
• Standard Operating Procedure
• Corrective and Preventive Action
• Good Laboratory Practice
• u.s. Food and Drug Administration
• Verification and Validation