Rasika (Tankhiwale) DeoAI in Compliance - Enhanced Regulatory Reporting & Workflows
Experience
Manuscript Consultant
R.D.V.V - Jbp
- Developed and managed content across diverse platforms, adapting tone, structure, and style to meet audience expectations and editorial standards
- Conducted in-depth research to ensure content accuracy, relevance, and alignment with client objectives and subject-matter requirements
- Edited and refined client manuscripts and drafts to improve clarity, narrative flow, coherence, and reader engagement
- Managed multiple concurrent content projects, prioritizing tasks and meeting tight deadlines while upholding high-quality standards
- Provided uncredited editing support for various publications, ensuring polished, consistent, and publication-ready final manuscripts
Quality Associate
BBSSW Medical Company
- Coordinated regulatory procedures and processes for medical devices, ensuring adherence to quality service functions and product portfolio standards
- Maintained comprehensive regulatory documentation archives, upholding ISO 13485, ISO 14971, and 21 CFR compliance with SOPs and regulatory mandates
- Conducted in-depth research and analysis for the timely preparation of regulatory submissions, including FDA premarket notifications and eCTD applications
- Established objectives and prioritized tasks in alignment with ISO 13485, FDA 21 CFR 820 and 11, ISO 14971, CAPA, EMEA, and ICH guidelines
- Engaged in cross-functional problem-solving sessions, applying expertise in quality principles and analytical skills
- Collaborated with manufacturing teams to enhance production processes, focusing on quality improvement and efficiency gains
- Utilized quality control software to monitor, track, and analyze product data, contributing to continuous quality improvement
- Consistently updated and managed quality control records and reports, ensuring accuracy and reliability of quality data
Doctoral Researcher
Wiley
- Conducted comprehensive research, resulting in the publication of manuscripts in prestigious journals and demonstrating exceptional skills in scientific publishing, editing, and presentation
- Increased research efficiency by optimizing data collection and analysis processes
- Collaborated with external researchers to create a diverse network for knowledge exchange
Research Associate
CSIR (PUSA) Institute
- Specialized expertise in polymer-controlled drug delivery systems, with a focus on synthesis, characterization, and nanotechnology
Senior Research Associate, Enhanced Regulatory Reporting & Workflow
CSIR (PUSA) Institute
- Specialized in the graft copolymerization of cellulose-based membranes to improve their antimicrobial properties for innovative food packaging solutions
- Developed innovative research strategies for improved data collection and analysis, leading to higher-quality results
- Created high-quality, professional articles for submission to scientific publications
- Published articles in peer-reviewed journals that enhanced the institution's reputation and contributed to scientific advancement
Industry Experience
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Experienced in Media and Entertainment, Healthcare, Biotechnology, Pharmaceutical, Chemical, and Food and Beverage.
Business Area Experience
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Experienced in Research and Development, Quality Assurance, Project Management, and Product Development.
Summary
As an experienced regulatory affairs and pharmacovigilance specialist, I bring a robust background in research and development, particularly in the cutting-edge fields of polymer drug delivery and nanotechnologies. My expertise lies in meticulously preparing and reviewing regulatory documents to ensure strict adherence to industry standards. I am a driven and detail-oriented professional with a passionate commitment to delivering sustainable healthcare solutions. My commitment to excellence makes me a valuable asset to any team seeking to navigate the complexities of regulatory compliance with precision and care.
Skills
- Regulatory Issues
- Pharmacovigilance And Drug Safety
- Quality Assurance In The Medical Industry
- Polymer Drug Delivery And Nanotechnology
- Iso 13485, Iso 14971, 21 Cfr
- Documentation Review
- Validation Protocols
- Quality Management System
- Medical Coding
- Medical Billing
- Revenue Cycle Management
- Regulatory Compliance
- Healthcare Administration
Languages
Education
R.D.V.V - Jbp
Master of Science · Chemistry · Jabalpur, India
R.D.V.V - Jbp
Bachelor of Science · Microbiology · Jabalpur, India
R.D.V.V - Jbp
Ph.D. · Chemistry · Jabalpur, India
Certifications & licenses
ISO 13485:2016 - Quality Management Systems For Medical Devices
ALISON
Extended International Pharmacovigilance And Argus Safety Certification
CCRPS
Medical Device And Process Validation
UDEMY
Ich Gcp For Clinical Research
UDEMY
Pharma Dra
UDEMY
Statistics
Experience
Global Experience
Expertise
Qualifications
Profile
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