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
Ankleshwar01-2011
S.S.C. -
Shree M.J. Bhatt Sarvajanik Vidhyalay
Mota01-2009
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
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