Summary
Overview
Work History
Education
Skills
Personal Information
Languages
Disclaimer
Regulatory Audits Exposure
Timeline
Generic
APEXA PATEL

APEXA PATEL

Bharuch

Summary

To secure a challenging position in Quality Assurance within a dynamic organisation, leveraging my technical skills and experience to contribute to successful operations and continuous improvement in a cGMP environment.

Overview

7
7
years of professional experience

Work History

Executive (QA)

Ami Organics Limited
Jhagadia
05.2024 - Current
  • Handle vendor qualification activities & prepare approved vendor lists for raw materials & packing material
  • Fill out Customer Questionnaires, prepare supporting documents and provide them to customers
  • Perform activities assigned by QA head on time
  • Conduct Process Validation
  • Preparation of annual product quality reviews
  • Handle Customer Audits with Stakeholders

Executive (QA)

GM Healthcare
Saykha
10.2023 - 05.2024
  • Preparation & Reviewing of SOPs and other cGMP Documents
  • Preparation of Batch production record of API & Intermediates with production persons
  • Preparation of Validation Master plan & Site Master Plan
  • Analytical data review and distribution of approved SOPs & STPs
  • Issue finished product labels to production & maintain reconciliation records
  • Review filled BMRs of APIs & Intermediates

Jr. Executive (QA)

Fermenta Biotech Ltd.
Dahej
09.2020 - 10.2023
  • Handle vendor qualification activities & prepare approved vendor lists
  • Support QMS activities including change control, deviation
  • Preparation of annual product quality reviews
  • Co-ordinate execution of internal audits
  • Reviewing and approval of change control related documents
  • Plant rounds & online monitoring of plant activities for GMP compliance
  • Document review & upload in DMS systems

QA Chemist

Meghmani LLP
Dahej
11.2018 - 09.2020
  • Review executed Batch Manufacturing Records prior to batch release
  • Issue Batch Manufacturing Records & coordinate with Production Department
  • Conduct annual product reviews for quality and yield assessment
  • Handle dispatch activities for local and export coordination
  • Maintain warehouse and excise department coordination

Education

B.Sc. - Chemistry

Narmada College of Science & Commerce
01-2015

H.S.C. -

S.V.E.M. Gujarati Medium School
Ankleshwar
01-2011

S.S.C. -

Shree M.J. Bhatt Sarvajanik Vidhyalay
Mota
01-2009

Skills

Quality Management Systems

  • Change Control
  • Deviations
  • APQR
  • Vendor Qualification

Documentation & Compliance

  • SOPs
  • BMRs
  • BPRs
  • Validation Master Plans
  • Site Master Plans
  • Data Integrity
  • CGMP

Auditing & Investigation

  • Internal Audits
  • Deviation Investigations
  • Regulatory Compliance

Technical Skills

  • Analytical Data Review
  • Batch Record Review
  • Product Quality Review
  • Document Management System (DMS)

Personal Attributes

  • Detail-oriented
  • Proactive
  • Strong Communication
  • Time Punctual
  • Willingness to Learn
  • Positive Approach

Personal Information

  • Date of Birth: 02/17/94
  • Nationality: Indian
  • Marital Status: Unmarried

Languages

  • Gujarati
  • English
  • Hindi

Disclaimer

I hereby declare that all the information furnished in this resume is true and correct to the best of my knowledge and belief. I am confident in my ability to perform at the highest level, both individually and as part of a team, to achieve organizational goals.

Regulatory Audits Exposure

Familiar with regulatory compliance requirements and actively contributed to maintaining audit readiness. Experienced in internal audits and preparation for external regulatory inspections.

Timeline

Executive (QA)

Ami Organics Limited
05.2024 - Current

Executive (QA)

GM Healthcare
10.2023 - 05.2024

Jr. Executive (QA)

Fermenta Biotech Ltd.
09.2020 - 10.2023

QA Chemist

Meghmani LLP
11.2018 - 09.2020

B.Sc. - Chemistry

Narmada College of Science & Commerce

H.S.C. -

S.V.E.M. Gujarati Medium School

S.S.C. -

Shree M.J. Bhatt Sarvajanik Vidhyalay
APEXA PATEL