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Dash Ghattu
Senior CSV Specialist at Minaris Regenerative Medicine
Professional Background
Dash Ghattu is an accomplished professional in the field of Computer Systems Validation (CSV) and Quality Assurance (QA), with extensive experience in compliance management, business analysis, and risk-based validation, particularly within the pharmaceutical domain. With a career spanning several prestigious organizations, Dash has cultivated a rich skill set that aligns seamlessly with the stringent requirements of the regulated healthcare industry.
Currently serving as a Senior CSV Specialist at Minaris Regenerative Medicine, Dash applies his expertise to ensure that products and systems meet the necessary regulatory compliance and quality standards. His role involves developing validation plans, quality assurance plans, and conducting information risk analyses. Dash is well-versed in the intricacies of the Software Development Life Cycle (SDLC) and is adept at technical writing, essential for creating detailed design specifications, requirements specifications, and test plans that meet regulatory expectations.
Prior to his current position, Dash made significant contributions at Hitachi Chemical Advanced Therapeutics Solutions, LLC, where he further honed his skills as a Senior CSV Specialist. His earlier experience includes a pivotal role as the SDLC Technical Writer and Validation Lead at Merck, providing him a solid foundation in both validation and technical documentation essential for compliance in pharmaceutical settings.
Throughout his career, Dash has held key positions in renowned organizations such as The Janssen Pharmaceutical Companies of Johnson & Johnson, Genentech, Eisai US, and Pfizer, where he has continuously demonstrated his capabilities in validation leadership and QA oversight. His multifaceted experience also encompasses deviation management, post-production monitoring, disaster recovery testing, and conducting thorough audits.
Education and Achievements
Dash Ghattu's academic background is characterized by solid footing in engineering, having earned a Master's degree in Industrial Engineering from the esteemed Govt. of Goa College of Engineering, located in Ponda, Goa. Prior to pursuing his master's, he completed a Bachelor's degree in Mechanical Engineering at Sri Jayachamarajendra College of Engineering in Mysore, equipping him with a strong technical foundation that has undeniably contributed to his success in the highly technical fields of validation and quality assurance.
Over the years, Dash has led numerous successful validation projects, ensuring compliance with Good Manufacturing Practices (GMP) and Good Automated Manufacturing Practice (GxP) regulations. His contributions to the field have not only enhanced the operational integrity of the systems he has worked on but have also ensured the safety and efficacy of the pharmaceutical products reaching consumers.
Skills and Expertise
Dash possesses an array of specialized skills that enhance his effectiveness in roles focused on computer systems validation and quality assurance. Among his proficiencies are:
- Risk-Based Validation: Expertise in identifying potential risks in processes and implementing appropriate validation strategies to mitigate them.
- Change Control Management: Adept at managing changes to existing systems and ensuring that all changes comply with regulatory standards and internal policies.
- Quality Management Systems: Knowledge in establishing and maintaining systems that uphold quality standards within pharmaceutical operations.
- Training and Development: Committed to fostering knowledge transfer within organizations, Dash has conducted several training sessions, particularly in Good Documentation Practices (GDP) and Tester training, which are integral in maintaining compliance.
- Collaboration and Communication: Exceptional ability to collaborate with cross-functional teams to ensure that all aspects of validation and quality assurance are addressed comprehensively.
Notable Achievements
Throughout his career, Dash has achieved a number of notable milestones that underline his commitment and expertise in the field:
- Participated in FDA Audits: Dash's involvement in FDA audits has solidified his reputation as a reliable compliance professional, showcasing his dedication to maintaining regulatory adherence in all aspects of pharmaceutical operations.
- Offshore Test Case Development: His experience extends to offshore test case development and execution, illustrating his adaptability and ability to manage international projects effectively.
- Developed a Range of Documentation: Dash has experience in generating critical documentation necessary for validation, including Validation Plans, System Testing, and User Acceptance Testing (UAT), all vital for successful project execution.
- Led Successful Remediation Plans: He has successfully led multiple remediation plans that have addressed compliance gaps, thereby enhancing the overall quality assurance processes within organizations.
Conclusion
Dash Ghattu is a highly skilled and experienced professional in the field of Computer Systems Validation and Quality Assurance. With a robust educational background, including advanced degrees in engineering, and significant industry experience across various leading pharmaceutical companies, Dash has established himself as an authority in compliance management and validation processes. His commitment to excellence and adherence to regulatory standards makes him an invaluable asset to any organization in the pharmaceutical and biotech sectors.
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