Vivek Ranjan

About Vivek Ranjan

Results-driven Team Lead having 8 years of experience in the medical device…

Experience

1. Site Validation Lead

   Stryker

   Aug 2023 — Present · Gurugram, IN

   Develop, implement, and oversee the global validation strategy, ensuring compliance with industry regulations (e.g, FDA, EMA, ISO) and internal standards.2. Assess the impact of new or updated regulations and adjust validation strategies accordingly.3. Collaborate with cross-functional teams (R&D, engineering, quality assurance, regulatory affairs) to ensure validation processes align with project timelines and milestones.4. Allocate resources effectively and ensure optimal team performance across multiple regions.5. Oversee the execution of validation activities for new systems, equipment, and processes across global sites, including computer system validation (CSV), equipment qualifications, and process validation.6. Ensure that all validation activities are well-documented, and that validation reports, protocols, and other documentation meet regulatory and internal requirements.7. Ensure all global validation processes comply with relevant local and international regulations, standards, and guidelines.8. Lead and support internal and external audits related to validation activities.9. Drive continuous improvement efforts to ensure the validation process remains efficient, effective, and compliant.10. Identify potential risks in the validation process and develop mitigation strategies to address these risks.11. Maintain proactive communication with key stakeholders to manage project timelines and expectations.12. Prepare and present reports to senior leadership regarding validation progress, issues, and results.13. Identify opportunities for process improvement and lead initiatives to enhance the efficiency and effectiveness of the validationprocesses14. Foster a culture of quality and compliance across all global validation activities.

Education

• Central university of Jharkhand

  Integrated M.Sc

  2012 — 2017