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
Similar Profiles
DAXESH JARIWALADAXESH JARIWALA
Manager - Marketing & Corporate Public Relations at Concept Medical & Envision Scientific Pvt Ltd.Manager - Marketing & Corporate Public Relations at Concept Medical & Envision Scientific Pvt Ltd.
HITESH SHARMAHITESH SHARMA
Director Sales at Concept MedicalDirector Sales at Concept Medical
Sharon AbraczinskasSharon Abraczinskas
Pharmacist at Concept MedicalPharmacist at Concept Medical
Jagdish DalabaraJagdish Dalabara
Assistant Business Manager at SHRIRAM FINANCE LIMITEDAssistant Business Manager at SHRIRAM FINANCE LIMITED
DHAVAL SOLANKIDHAVAL SOLANKI
Project Manager at Treta Infotech PVT LTDProject Manager at Treta Infotech PVT LTD