Shruti Panchal
Mumbai
Summary
I am looking ahead to work in a professional, growth oriented organization, where in one can make significant contribution to the success of the organization. Seeking a position that involves creativity, challenges and that provides me, an opportunity to constantly strive to explore, innovate & excel in attaining organizational and my individual goals. A consistently dependable team player, I can thrive in a high-pressure environment, enjoy the challenges of meeting deadlines and work in a team.
Overview
8
8
years of professional experience
1
1
Certification
Work History
Specialist, Quality Assurance
Biorasi CRO Services Pvt Ltd.
06.2020 - 03.2025
- Develop and maintain GCP/ICH compliant processes which control the quality of work and clinical trials
- Assist activities in the areas of Internal Quality Audits, CAPA (Corrective and Preventive Actions), Production support, Quality Management Reviews, and Quality Audits
- Conduct or assist in auditing activities to ensure that studies are conducted in accordance with sponsor protocols, GCP, industry guidelines, agency regulations
- Assist with identifying non-conformances with requirements, provide suitable recommendations and facilitate ongoing quality improvements using risk-based methodology while maintaining compliance with applicable study protocols, Quality System Regulations and or ISO standards where applicable
- Create, write or edit Standard Operating Procedures (SOPs), procedures, and forms
- Assist in conducting vendor audits and work with vendors and production support personnel in eliminating problems via root cause analysis techniques, to ensure that product quality continuously improves
- Provide Non-debarment certificates to site staff before SSV
- Support special projects requiring QA input
- Perform other related duties as assigned
- Perform TMF QC and document review for study documents
- Coordinate, facilitate, and track to completion development and revisions of Controlled Documents and Quality Records
- Assist with and hosting clients / sponsors, regulatory /certification audits (external), internal audits and inspections, its processes and studies by retrieving, QC, and providing the Controlled Documents and Quality Records for presentation to the auditor's and inspectors
- Participate and present at the external and internal audits and inspection on the topics related to the Document Control process
- Assist with internal processes and quality systems and vendor audits - develop and maintain tools, trackers, and eQMS reports; follow up on outstanding action and deliverables
- Assist and collaborate with Information Technology, Process Agility CQA, L&D functions on implementation the quality management processes and initiatives
- Adhere to applicable national and international laws, regulations, and guidances (or sections thereof) governing clinical trials, including, but not limited to applicable the Good Clinical Practices (GCPs), and ISO certification
- Comply with company policies, standard operating procedures (SOPs), operating guidelines, and other written instructions
- Review and creation of SOPs, Work instructions, Forms, Templates and checklists
Clinical Study Associate
09.2019 - 06.2020
- Support Global Study Leaders (GSL) and Global Study Managers (GSMs) by completing delegated study work
- Upload, Index documents on the behalf of study team
- Initiate the set-up, maintain and close the electronic Trial Master File (eTMF) to ensure compliance to International Conference of Harmonization Guidelines for Good Clinical Practice (ICH/GCP) and SOPs
- Support study team in study TMF review
- Maintain study details in CTSM system (Add/remove users, add dates, roles)
- Partner with internal functions and external vendors in collection of regulatory and other documents
- Provide study specific system access to study members
- Maintain study specific rooster
- To initiate and maintain production of study documents, ensuring template and version compliance per study specific requirements
- Oversee and attend internal and external meetings e.g
- Study team meetings, committee meetings, monitor meetings, Investigator meetings and virtual meetings
- Liaise with internal and external participants and/or vendors
- Systems Used: eTMF (D2, Veeva Vault), IxRS, CTMS, QMS
eTMF Document Specialist
Tata Consultancy Services Limited
05.2019 - 09.2019
- Process study documentation in accordance with Standard Operating Procedures (SOPs), Work Instructions (WIs), GCP, ICH guidelines and study specific TMF Plans
- Support the set-up, maintenance, and closure of TMF repositories
- Support documentation collection activities, including: Document scanning and indexing for trial using an electronic TMF Document filing for trials using a paper TMF
- Perform quality review of documents submitted for entry into the TMF and liaise with project teams to resolve any issues identified
- Maintain compliance with departmental quality, performance and utilization targets
- Complete administrative tasks (e.g., status reports) as requested
- Participates in preparation/reconciliation of TMF documentation related to audits, inspections
Junior Data Analyst
PharmaTargeting Research Private Limited
Mumbai
05.2017 - 04.2019
- Data Research
- Pipeline Drug Data Research
- Project Management
- Advance Excel
- Data Extraction.
- Market Research (primary and Secondary)
Medical Conference Coordinator of Technical Division
Pioneer Century Science, India
10.2015
- Data collection and speakers selection according to assigned project
- Projects worked on: Stem Cell, Neurology, Gynecology, Urology, Pulmonology, Cardiology
- Access Medical Journals And online Publications
- Web Research
Education
M.Sc - Bio-Tech
Viva College of Arts, Commerce & Science
01.2014
B.Sc - Bio-Tech
Viva College of Arts, Commerce & Science
01.2012
H.S.C -
Viva College of Arts, Commerce & Science
01.2009
S.S.C -
Utkarsha Vidhyalaya
01.2007
Skills
- Quality assurance
- Quality audits
- GCP Compliance
- SOP development
- Risk management
- Document control
- Project management
- Vendor management
- Deviation and CAPA Management
- Root cause analysis
- Document Management
Certification
Advanced Certification Course in Clinical Research
NIDA GCP Certification
Research Dissertation
Comparative Assessment Of Proximate And Heavy Metal Content Of Vegetables Grown With Fresh Water And Wastewater
Languages
- English
- Hindi
- Marathi
Hobbies and Interests
- Gardening
- Travelling
Disclaimer
I hereby declare that the details furnished above are true to the best of my knowledge.
References
Available on request
Extra Qualifications
One day certificate course in the hand on training programme on PCR by National facility of Biopharmaceuticals (NFB).
References
References available upon request.
Timeline
Specialist, Quality Assurance
Biorasi CRO Services Pvt Ltd.
06.2020 - 03.2025
Clinical Study Associate
09.2019 - 06.2020
eTMF Document Specialist
Tata Consultancy Services Limited
05.2019 - 09.2019
Junior Data Analyst
PharmaTargeting Research Private Limited
05.2017 - 04.2019
Medical Conference Coordinator of Technical Division
Pioneer Century Science, India
10.2015
M.Sc - Bio-Tech
Viva College of Arts, Commerce & Science
B.Sc - Bio-Tech
Viva College of Arts, Commerce & Science
H.S.C -
Viva College of Arts, Commerce & Science
S.S.C -
Utkarsha Vidhyalaya
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