Dinesh Kumar A
B.Tech Pharmaceutical Technology
Krishnagiri
Summary
Dynamic Quality Assurance Professional with extensive experience at Maiva Pharma Private Limited, excelling in process validation and compliance with GMP standards. Proven expertise in documentation management and cross-functional collaboration, ensuring successful FDA audits and effective change control. Strong analytical skills complemented by a commitment to quality and customer satisfaction.
Overview
1
1
year of professional experience
Work History
Quality Assurance Professional
Maiva Pharma Private Limited
Hosur, India
11.2024 - 03.2026
- Involved in process validation activities (prospective, concurrent, re-validation) in injectable.
- Preparation, review, and execution of Process Validation Protocols and Reports.
- Preparation, review, and execution of hold time study protocols and reports for bulk, intermediate, and finished products.
- Preparation and review of Batch Manufacturing Record and Batch Packing Record.
- Coordination with Production, QC, and Engineering during validation activities.
- Supporting the FDA audit for new line qualification approval.
- Ensure compliance with GMP, GDP, and data integrity requirements.
- Monitoring of critical process parameters and validation.
- Support during internal, customer, and regulatory audits.
- Addressing the customers' queries related to the process and procedure.
- Coordinate with the CFT for the new projects evaluation strategy.
- Change control and CAPA initiation, review, and timely closure.
Education
B.Tech Pharmaceutical Technology
Gnanamani Collega Of Technology/Anna University
Namakkal, IndiaSkills
Quality management systems
Documentation management systems
Progeny ERP
Track wise
Power Point
MS Office
Declaration
I, hereby that the information furnished above is true to the best of my knowledge
Timeline
Quality Assurance Professional
Maiva Pharma Private Limited
11.2024 - 03.2026
B.Tech Pharmaceutical Technology
Gnanamani Collega Of Technology/Anna University