Kevin Pinto

About Kevin Pinto

A proficient expert with over 17 years of experience in Pharmaceutical Quality Assurance, Product Life Cycle Management, External Supply and Manufacturing of Parenteral and Oral dosages. Global Business Process Owner for Deviation, Change Control, Investigation, and CAPA ManagementGovernance and oversight of quality documents and processes.Proficient knowledge and expertise in Pharmaceutical QMS, Regulatory and Manufacturing processes and systems. Excellent communication with problem solving and analytical skills.

Experience

1. Change Control Lead

   Opella

   Jul 2024 — Present · Hyderabad, IN

   Global Business Process Owner for Deviation, Change Control, Investigation, and CAPA ManagementAct as the Global Business Process Owner for the applicable quality processes and the Veeva QMS Tool. Ensure the process and system workflows are efficient and easy to use, and developing clear training materials to support daily operations.Ensuring strict operational compliance to global quality standards, GxP protocols and legal requirements.Prepare and update Global Quality Documents for the respective quality processes and embedding risk management principles in the outputs.To deliver targeted training to stakeholders.Define business needs and objectives for the continuous development and maintenance of the Enterprise Veeva Vault Platform including creating custom features, objects, fields and workflows.Spearhead ongoing improvement efforts by defining priorities and managing a backlog of enhancements on JIRA and Confluence. Lead the execution of corporate strategies, particularly through transversal projects and supporting digital application rollouts related to quality and compliance.Champion harmonized processes and continuous improvement initiatives by prioritizing and managing process and system improvements to ensure consistency and efficiency.Establish key performance indicators to support thorough data analysis, trend identification, and detailed reporting.Establish and maintain networks with the manufacturing sites, external manufacturers, country affiliates, and other global GxP functions to support cross-functional collaboration and sharing of best practices.Facilitating the integration of emerging regulatory requirements into global operational processes.Offer leadership and specialized support regarding quality and compliance matters like audit support and subject matter expertise.

Education

• Indian School of Business

  General Management Program

  2019 — 2020

• University of Mumbai

  Bachelor's degree, Zoology

  2003 — 2006

Skills

• Technology Transfer
• Glp
• Formulation
• Cgmp Manufacturing
• Gmp
• 21 Cfr Part 11
• Cleaning Validation
• Pharmaceutics
• Deviations
• Biotechnology
• Biopharmaceuticals
• Standard Operating Procedure (Sop)
• Quality Auditing
• Aseptic Processing
• Validation
• Change Control
• Life Sciences
• Quality Assurance
• Capa
• Manufacturing
• Pharmaceutical Industry
• Sop
• Fda
• Regulatory Affairs
• Regulatory Requirements
• Quality System
• V&V