Sona Paul
@sonapaul
Experienced QA/RA Executive with expertise in quality management and regulatory compliance.
IndiaWhat I'm looking for
As a dedicated QA/RA professional, I bring a strong background in developing and implementing comprehensive quality and regulatory strategies. My experience includes ensuring compliance with global standards, managing audits, and leading cross-functional teams to achieve organizational goals.
In my current role as a QA/RA Officer, I have successfully implemented regulatory compliance strategies and overseen internal and external audits. My previous role as a Clinical Research Coordinator honed my skills in managing clinical trials and ensuring adherence to GCP and FDA regulations.
I am passionate about continuous process improvement and talent development, ensuring that teams and processes align with long-term objectives. My analytical mindset and attention to detail drive my commitment to maintaining high-quality standards in all aspects of my work.
Experience
Work history, roles, and key accomplishments
CSQuality Assurance / Regulatory Affairs Officer
Clinovex Clinical Research Solutions
Jun 2024 - Present (11 months)
Responsible for developing and implementing quality and regulatory programs to ensure compliance with global market requirements. Collaborates with R&D and Marketing to provide regulatory guidance, oversees audits, and maintains inspection readiness.
CSClinical Research Coordinator
Clinovex Clinical Research Solutions
Oct 2022 - Jan 2024 (1 year 3 months)
Coordinated clinical trials in cardiology, ensuring compliance with GCP guidelines and FDA regulations. Managed patient recruitment, data collection, and regulatory binders while monitoring patient safety and adherence.
Education
Degrees, certifications, and relevant coursework
Clinovex Clinical Research Solutions
Diploma, Clinical Research Management
2024 -
Pursuing a Diploma in Clinical Research Management, focusing on regulatory compliance and quality assurance in clinical trials.
MMM.E.S. College, Marampally
Master of Science, Biotechnology
Earned a Master of Science in Biotechnology, enhancing knowledge in advanced biological concepts and research methodologies.
MMM.E.S. College, Marampally
Bachelor of Science, Biotechnology
Completed a Bachelor of Science in Biotechnology, focusing on the principles of biological sciences and their applications in various fields.
Tech stack
Software and tools used professionally
Availability
Location
IndiaAuthorized to work in
Job categories
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