Ratnakar Josyula

FAQ About Ratnakar Josyula

• What is Ratnakar Josyula's address?

  Ratnakar Josyula is located at
  New Haven, Connecticut, United States

• What is Ratnakar Josyula's job title?

  Ratnakar Josyula is a
  As a Sr. Manager and Quality Events Assessment and Investigation Lead at Pfizer, I have over 11 years of experience in the pharmaceutical and biotechnology industry, with a strong focus on regulatory affairs, quality management, and clinical research. I am a trained ISO 9001:2015 Quality System Auditor, a Certified Quality Auditor (ASQ-CQA) and a Regulatory Affairs Certified (RAC) professional, with a thorough knowledge of FDA and global regulatory requirements for drugs, biologics, medical devices, and diagnostics. My core competencies include managing GCP deviations qualifying as Significant Quality Events (SQEs), investigating and implementing Corrective and Preventive Actions (CAPA) plans, conducting Root Cause Analysis (RCA), performing internal audits, writing and reviewing quality documents, and mentoring and training colleagues. I have successfully managed over 160 GCP quality events, including 20 that occurred in COVID-19 trials, ensuring compliance, quality, and safety. I have also developed and implemented a tool for maintaining inspection readiness and quick record retrieval, which was recognized as a best practice within the organization. Additionally, I have a background in molecular-biology research. My mission is to contribute to the advancement of science and medicine by ensuring the highest standards of quality and integrity in clinical trials and research. I am passionate about continuous improvement of processes, learning new skills that contribute to my work, collaborating with cross-functional and multi-disciplinary teams, and delivering value to the organization and the society. Pfizer

• What industry does Ratnakar Josyula currently work in?

  Ratnakar Josyula currently works in the
  Pfizer

• What is Ratnakar Josyula's area of expertise?

  Ratnakar Josyula specializes in
  As a Sr. Manager and Quality Events Assessment and Investigation Lead at Pfizer, I have over 11 years of experience in the pharmaceutical and biotechnology industry, with a strong focus on regulatory affairs, quality management, and clinical research. I am a trained ISO 9001:2015 Quality System Auditor, a Certified Quality Auditor (ASQ-CQA) and a Regulatory Affairs Certified (RAC) professional, with a thorough knowledge of FDA and global regulatory requirements for drugs, biologics, medical devices, and diagnostics. My core competencies include managing GCP deviations qualifying as Significant Quality Events (SQEs), investigating and implementing Corrective and Preventive Actions (CAPA) plans, conducting Root Cause Analysis (RCA), performing internal audits, writing and reviewing quality documents, and mentoring and training colleagues. I have successfully managed over 160 GCP quality events, including 20 that occurred in COVID-19 trials, ensuring compliance, quality, and safety. I have also developed and implemented a tool for maintaining inspection readiness and quick record retrieval, which was recognized as a best practice within the organization. Additionally, I have a background in molecular-biology research. My mission is to contribute to the advancement of science and medicine by ensuring the highest standards of quality and integrity in clinical trials and research. I am passionate about continuous improvement of processes, learning new skills that contribute to my work, collaborating with cross-functional and multi-disciplinary teams, and delivering value to the organization and the society.

• Which languages does Ratnakar Josyula speak? 

  Ratnakar Josyula speaks the following languages:
  No languages available.

• Which industries has Ratnakar Josyula previously worked in?   

  Ratnakar Josyula has prior experience in the following industries:
  Yale School Of Public Health , Yale University School Of Medicine , University Of Alabama At Birmingham

• What is Ratnakar Josyula’s work experience?  

  Ratnakar Josyula has the following professional experience:
  Pfizer , Yale School Of Public Health , Yale University School Of Medicine , University Of Alabama At Birmingham .

• How can I find Ratnakar Josyula on LinkedIn?  

  You can view Ratnakar Josyula’s
  LinkedIn profile at LinkedIn URL.

• What are Ratnakar Josyula’s work email addresses?  

  Ratnakar Josyula’s work email addresses are
  [email protected] .

• What company does Ratnakar Josyula work for?  

  Ratnakar Josyula works at
  Pfizer