Jigisha Prajapati
Surat
Summary
Hardworking and dedicated Quality Assurance And Regulatory Affairs successful at preparing and documenting paperwork.
Overview
6
6
years of professional experience
Work History
Associate Quality Assurance
Concept Medical (Envision Scientific)
Surat
09.2019 - 12.2021
- Ensure product quality.
- Documented processes for quality assurance activities such as inspections, tests, audits, and reviews.
- Identified defects in products using test plans and documented results.
- Analyzed customer complaints and identified root causes of issues.
- Provide QA related document to Regulatory Affairs for submission applications in accordance with relevant international standards.
- Performed gap analysis between current regulations and proposed changes in legislation.
- Conducted internal audits to assess compliance with ISO 13485 requirements.
- Developed and implemented quality management system processes, procedures and standards.
- Reviewed established procedures to assess areas in need of improvement.
- Review the packing material (Labels,Outer Box, Brochure) and provide control number with history details.
- Handling change controls and maintains documents related change controls.
- Review validation protocol and reports.
Quality Assurance Executive
J.B. Pharmaceutical Laboratory. Pvt.ltd
Panoli
03.2017 - 03.2019
- Product Registration document submitted to regulatory bodies.
- Ensured that all products meet established standards before being released for sale or distribution.
- Created detailed reports outlining the results of inspections, tests, audits.
- Prepare, Review and Implement standard operating procedures.
- Prepare Annual Product Review (APR).
- Handling software Document Management system (DMS).
Regulatory Affairs Officer
ICPA Health Products Limited
Ankleshwar
01.2016 - 02.2017
- Prepared technical documents including Summary Technical Documents, Clinical Evaluation Reports
- Performed gap analysis of current processes against best practices standards set by regulatory bodies.
- Developed, maintained and updated procedures for registration of products in different countries.
- Conducted due diligence activities for product registrations to ensure compliance with local requirements.
- Collaborated with cross-functional teams such as Quality Assurance, Manufacturing, Marketing. to ensure compliance with relevant regulations.
- Prepared technical documents including Summary Technical Documents, Clinical Evaluation Reports and Design Dossier.
Education
M.pharm - Quality Assurance
Parul Institute of Pharmacy
Vadodara 04-2015
B.Pharm - Pharmacy
Vidhyabharti Trust College of Pharmacy
Umrakh04-2013
Skills
- Test Reporting
- Test Planning
- ICH Guideline
- ISO 13485 QMS for Medical devices
Timeline
Associate Quality Assurance
Concept Medical (Envision Scientific)
09.2019 - 12.2021
Quality Assurance Executive
J.B. Pharmaceutical Laboratory. Pvt.ltd
03.2017 - 03.2019
Regulatory Affairs Officer
ICPA Health Products Limited
01.2016 - 02.2017
M.pharm - Quality Assurance
Parul Institute of Pharmacy
B.Pharm - Pharmacy
Vidhyabharti Trust College of Pharmacy
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