Summary
Overview
Work History
Education
Skills
Certification
Interests
Personal Information
Technical Paper Presented
Accomplishments
Affiliations
Software
Work Availability
Work Preference
Languages
Quote
Timeline
Generic
Hiral Patel

Hiral Patel

Quality Assurance & Regulatory Affairs
Sachin

Summary

Innovative, enthusiastic, self-motivated individual with a passion for Life Sciences. Seeking a challenging position to develop current skills and push boundaries in the field. Excited to contribute to a team that values creativity, problem-solving, and continuous learning.

Overview

15
15
years of professional experience
8
8
years of post-secondary education
4
4
Certifications
3
3
Languages

Work History

Assistant Manager QA/QC/RA

Dolphin Life Science India LLP
Surat
01.2020 - Current
  • USFDA registration and Submission, device listings, Responsible for manufacturing license application, Responsible for applications for brand approval, FSC, NCC, MSC, QMS & etc. from CDSCO using online CDSCO portal, Responsible for Preparation of Technical files for international submission, Responsible for product registration in , QMS Update, Risk Management, PMCF, PSUR, GSPR, IFU, labelling, provide regulatory support in documentation update for EU MDR requirements, Preparation of EU technical documents etc.
  • Responsible for Preparation & review of Technical files (Product License, DMF, SMF), CAPA, Internal Audit, Documents Creation and Change, Provide training on ISO13485, Quality Policy, Quality Objectives etc.
  • Preparation of SOP, product Specifications, Test methods, Quality formats, BMR compilation & review, IPQC/ IPQA activities, Finished product/Packaging material data for the purpose of compilation of the dossier etc.
  • Coordinated with cross-functional teams to provide regulatory support, Responsible for Batch Release.
  • Responsible for all In-process activities, Review and compilation DHRs, Document preparation, Conduct internal Audits etc.
  • Reviewing and approving physical and microbiological environment monitoring data.
  • Executing all QA functions i.e. NCR, CAPA, Deviations, IQA and so on.
  • ETO sterilization Validation, Sealing Machine Validation.
  • Perform Hardware End of line test, Software End of line test, Electrical Safety test for Lupin Dental Robotic System in Dolphin Life Science.
  • Independently prepare DMF & apply MD-26 & manufacturing License of world’s first polymeric heart valve by Foldax INC. TRIA mitral Heart valve in Dolphin Life Science.
  • Developed strong working relationships with staff, fostering a positive work environment.

Biology and Science / Math's Teacher

Saraswati Hindi Madhyamik School
Sachin, Surat
04.2014 - 01.2018
  • Developed strong relationships with students, parents, and colleagues by maintaining open lines of communication and fostering a supportive learning environment.
  • Managed classroom behavior effectively by establishing clear expectations, modeling appropriate conduct, and consistently enforcing established rules and consequences.
  • Maintained accurate records of student progress, attendance, and behavior to facilitate ongoing communication with parents about their child''s educational journey.
  • Enhanced classroom engagement through the use of interactive teaching methods, such as group projects and hands-on activities.
  • Identified struggling students early on and provided additional support through tutoring sessions and modified lesson plans.
  • Mentored new teachers, sharing best practices and providing guidance to help them adapt to their new roles successfully.

QC Chemist & Microbiologist

Veritas Bioventiones Pvt Ltd
Vapi
03.2012 - 11.2013
  • Looking after all QC & microbiology activities (For dental product also) for all raw material, Packing material, In process testing, Finished Product testing & related documentation.
  • Handle HPLC operations like Drug loading test, Drug Release test, Drug Coating Solution analysis, HPLC Calibration, Analytical Method Validation, Drug Degradation analysis, Column Performance checking.
  • Microbiology activities like media preparation, plate pouring, Environment monitoring, Sterility testing, sub culturing etc.
  • Performed standard and proprietary physical testing and chemical analysis of raw chemical materials and finished products.
  • Reviewed raw material specifications to ensure compliance with industry standards and regulatory requirements.
  • Operated specialized scientific equipment and performed complex procedures to execute high-level analytical testing tasks.
  • Generated technical reports and other documentation to record analytical test results and conclusions.

Q.C. Executive

Invent Bio Med Pvt. Ltd
Sachin, Surat
04.2010 - 03.2012
  • Looked after all QC activities like inward raw material sampling, analysis, approval/ rejection, all documentation, In-process testing, Finished Product testing, water testing, formats preparation, STP, SOP, SPF Preparation, Documentation related to Regulatory affairs.
  • Maintained detailed records of all QC activities, facilitating easy retrieval for audits or investigations as needed.
  • Mentored junior staff members, helping them develop their skills and advance within the organization.
  • Improved product quality by implementing rigorous testing procedures and protocols.
  • Evaluated equipment performance, recommending upgrades or replacements when necessary to maintain optimal output quality levels.
  • Coordinated with regulatory agencies to address any non-compliance issues promptly and effectively.
  • Led a team of quality control professionals to ensure adherence to industry standards and regulations.

Education

Bachelor of Education -

Jay Gayatri Education Trust
Bheshtan, Surat
03.2013 - 06.2014

Master of Science - Bioinformatics

Veer Naramad South Gujarat University
Surat, Gujarat
05.2007 - 06.2009

Bachelor of Science - Micro

B.P.Baria Science Institute
Navsari, India
06.2004 - 05.2007

H.S.C. -

R.S.M Poonawala Sarvajanik Experimental School
Surat, India
04.2003 - 05.2004

S.S.C -

R.S.M Poonawala Sarvajanik Experimental School
Surat, India
04.2001 - 05.2002

Skills

Regulatory Compliance: Indian MDR 2017, ISO13485:2016, EU MDR 2017/745, MDD 93/42/EEC, 21 CFR 820

Certification

Certified Internal Auditor for ISO 13485:2016

Interests

Reading
Surfing
Learn New Things

Personal Information

  • Date of Birth: 05/15/86
  • Gender: Female
  • Marital Status: Married

Technical Paper Presented

Gene Fusion, Presented a Seminar on 'Gene Fusion' as a part of Syllabus.

Accomplishments

    Successfully closer of ANVISA Audit & USFDA Audit for IAB Catheter.

Affiliations

· Certified Internal Auditor for ISO 13485:2016

· Training certificate for IEC 60601-1 & 60601-2

· Training from Foldax INC. on stitching PTFE sewing ring with heart valve using polyester suture.

eDHR software training & heart valve quality inspection by Foldax INC.

Software

Bioinformatics Software : BIOSUIT, ARGUSLAB, HYPERCHEM, SWISSMODEL, RASMOL, SWISS PDB- VIEWER, FAF Drug, Corina , BLAST, FASTA, DDBJ, PASS, CLUSTAL-W, ORF FINDER Database : KEGG, PUBCHEM, NCBI, PUBMED, PDB

Work Availability

monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
swipe to browse

Work Preference

Work Type

Full Time

Work Location

RemoteOn-SiteHybrid

Important To Me

Career advancementWork-life balanceCompany CultureFlexible work hoursHealthcare benefitsWork from home optionStock Options / Equity / Profit Sharing

Languages

English
Advanced (C1)

Quote

Judge a man by his questions rather than his answers.
Voltaire

Timeline

Assistant Manager QA/QC/RA

Dolphin Life Science India LLP
01.2020 - Current

Biology and Science / Math's Teacher

Saraswati Hindi Madhyamik School
04.2014 - 01.2018

Bachelor of Education -

Jay Gayatri Education Trust
03.2013 - 06.2014

QC Chemist & Microbiologist

Veritas Bioventiones Pvt Ltd
03.2012 - 11.2013

Q.C. Executive

Invent Bio Med Pvt. Ltd
04.2010 - 03.2012

Master of Science - Bioinformatics

Veer Naramad South Gujarat University
05.2007 - 06.2009

Bachelor of Science - Micro

B.P.Baria Science Institute
06.2004 - 05.2007

H.S.C. -

R.S.M Poonawala Sarvajanik Experimental School
04.2003 - 05.2004

S.S.C -

R.S.M Poonawala Sarvajanik Experimental School
04.2001 - 05.2002

Similar Profiles

CREATE PROFILE
Hiral PatelQuality Assurance & Regulatory Affairs