Bijoy Kuzhiplavil Joy
Bin Omran,Qatar
Summary
An experienced, committed and passionate individual who has good knowledge of Quality and Compliance management standards, Clinical Research principles and the best practice in continuous Quality Improvement methodologies. Well versed with JCI standards, international regulations and Good Clinical practice.
Overview
14
14
years of professional experience
3
3
Languages
Work History
Quality Management Coordinator, Research & Regulatory Associate
Aaranya Management Services (AMSPL)- Freelance
01.2019 - Current
- Quality & Auditing: Implementing and maintaining Quality Management and Improvement system requirements, including preparing quality documents & SOPs, conducting audits, and training clients on QMS requirements. (Achieved 90% improvement in quality processes)
- Regulatory: Provided regulatory support and ensured compliance with statutory requirements, resulting in 50% reduction in compliance issues.
- Clinical Research: Remote monitoring of trial sites based upon requirements of study protocol. Review all clinical trial documents, verify that investigator is enrolling only eligible subjects, regulatory document review, assess research site’s patient recruitment and retention success
Sr. Quality Management & Regulatory Affairs Specialist
Bio-Rad Healthcare India
Delhi, India
09.2013 - 01.2019
- Quality: Assured quality and timely delivery of business processes, products, and services with consistent adherence to quality methodologies, resulting in {98%} customer satisfaction rate.
- Audited processes and procedure for ISO and quality standards compliance, achieving 90% compliance rate.
- Documented non-conformance, recommended corrections, and presented audit findings to all levels of management.
- Coordinated and managed key aspects of regulatory and accreditation requirements, resulting in 100% compliance for organization.
- Monitored, tracked, compiled, and collected Data for Quality Improvement and Quality Management, leading to 20% improvement in overall quality.
- Risk Management: Planned and conducted risk assessments for all departments in a healthcare setting, analyzed and updated risk register, and maintained records of hazards and control measures. Investigated incidents through root cause analysis, initiated CAPA, and compiled risk reports, resulting in {15%} decrease in safety incidents.
- Regulatory: Managed an international team of regulatory personnel to develop a global registration process, which led to registration of over 700 product for corporate rebranding & commercialization project.
- Submitted dossiers to renew and obtain marketing authorization licenses on drug products with 95% success rate.
- Clinical Research: Ensured adherence to Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Research practices (GRP). Achieved a 60% increase in successful trial completion rate.
- Interacted and communicated effectively with PI/Research Team at site to ensure ethical conduct of research according to approved research protocol. Trained staff on study protocol and offered all necessary administrative, financial, and logistic support as and when required. Achieved 85% improvement in staff performance.
Sr. Executive- Regulatory Affairs & Marketing
Bovian Healthcare India
Delhi, India
05.2013 - 06.2013
- Developed and executed regulatory plans for new product registrations, drove labeling process, prepared and compiled registration dossiers to be submitted for federal licensing applications. Achieved {30%} increase in successful product registrations.
- Developed marketing plans based upon extensive research and prospects targeted
- Stayed current on changes in federal and state laws and communicated changes to team members to mitigate risks
Regulatory Affairs Officer
Covidien Healthcare India
Delhi, India
06.2012 - 04.2013
- Preparation and compile registration dossiers.
- Monitor any regulatory changes.
- Establish contacts within local competent authorities and liaise with them.
- Reporting of any Serious Adverse Events/ Adverse Events or recalls to concerned regulatory authority
Sr. Clinical Research Coordinator
Apollo Hospitals Education & Research Foundation India
09.2009 - 02.2012
- Coordinated, organized, and maintained all study documentation including source documentation, case report forms, study regulatory binders, and patient binders.
- Screened subjects from daily schedule and confirmed eligibility of potential study subjects.
- Recruited approximately 120 subjects for various studies and administered informed consent. Achieved 80% successful enrollment of subjects.
- Scheduled study visits and necessary testing including procuring blood, urine, serum and intestinal specimens.
- Prepared and processed all documentation through Institutional Review Board (IRB), including submissions, continuing reviews, amendments, and adverse event reporting.
- Conducted monitoring visits to confirm protocol compliance, assess qualifications of study personnel, ensure "Good Clinical Practice", and conduct close-out visits. Achieved 98% adherence to trial protocols.
- Maintained effective/ongoing communication with research participants/sponsors resulting in 90% increase in customer satisfaction.
- Coordinated appropriate and timely payments to participants, ensuring sustained enrollments with 20% increase in participant retention.
- Maintained IRB annual renewals and refined research protocols; designed source document format for multiple data capture & acted as liaison with physician and drug companies.
- Prepared for and participated in audits conducted by sponsors and other oversight entities such as regulatory authorities, resulting in 100% compliance with industry guidelines.
- Assisted in design/execution of programs that contributed to 32% growth of trial within one year.
- Executed and supervised 8 clinical research studies at single time, from recruitment of subjects to end of study.
Education
MS in Clinical Research - Clinical Research & Data Management
Cranfield University
United Kingdom06.2010
Post Graduate Diploma in Clinical Research Management - Clinical Research Management
Institute of Clinical Research
Delhi (India)06.2010
B.Sc. Biotechnology - Biotechnology, Microbiology, Biochemistry..
Mahatma Gandhi University
Kerala, India05.2007
Skills
- Quality Management & Improvement
- Internal Audit
- Clinical Trials Data Management
- IRB Management
- Risk Management & Patient Safety
- Project Management
Languages
English Proficient
Hindi Proficient
Malayalam Native
Training
- Quality & Safety in Healthcare
- Laboratory Quality Management
References
- Mr. Sujit Srivastava, Head of Operations- AMSPL, +91-9899566822
- Mr. Ramesh Pandey, RA & QA Manager- Bio-Rad Healthcare, +91-9811943408
Awards
Best Commercial Support2018 (Bio-Rad Healthcare)
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Certification
Certified Lead Auditor for ISO 9001:2015 (DNV-GL)
Interests
Music and Travelling
Timeline
Quality Management Coordinator, Research & Regulatory Associate
Aaranya Management Services (AMSPL)- Freelance
01.2019 - Current
Sr. Quality Management & Regulatory Affairs Specialist
Bio-Rad Healthcare India
09.2013 - 01.2019
Sr. Executive- Regulatory Affairs & Marketing
Bovian Healthcare India
05.2013 - 06.2013
Regulatory Affairs Officer
Covidien Healthcare India
06.2012 - 04.2013
Sr. Clinical Research Coordinator
Apollo Hospitals Education & Research Foundation India
09.2009 - 02.2012
MS in Clinical Research - Clinical Research & Data Management
Cranfield University
Post Graduate Diploma in Clinical Research Management - Clinical Research Management
Institute of Clinical Research
B.Sc. Biotechnology - Biotechnology, Microbiology, Biochemistry..
Mahatma Gandhi University
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