M. Augustus Oswin
Pondicherry
Summary
Experienced Quality Assurance professional with a strong background in the pharmaceutical industry. Specializes in batch record review, compliance, and regulatory standards. Brings a wealth of knowledge and expertise to any organization. Goal is to contribute to a progressive company that prioritizes delivering high-quality products.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Senior Executive, Quality Assurance
Strides Pharma Science International Limited
04.2022 - Current
- Review of New product introduction & Gap Assessment, Protocol, Manufacturing records for execution of batches, Quality Risk assessment. Compliance with approved dossier. Witness the manufacturing operations of new product/ site transfers.
- Perform Root cause investigations related to manufacturing deviations.
- Continuous process verification of products through collection of trend data, Statistical analysis(Minitab) & interpretation, improved the product and its process robustness by reducing variation and optimizing it. Ensure the continued state of product compliance and periodic monitoring.
- Implemented risk management strategies to identify potential areas of concern and proactively address them before they became critical issues.
- Support production startup activities, including New Product Introductions (NPI), changeover activities, and equipment releases
Junior Executive, Quality Assurance
Apex Laboratories Private Limited
12.2018 - 03.2022
- Review and approve Master Batch Records and subsequent batch records for intermediates and active pharmaceutical ingredients (APIs), ensuring compliance with quality standards and regulatory specifications
- Evaluate QC lab worksheets for intermediates, APIs, and cleaning samples, ensuring adherence to established guidelines
- Prepared and reviewed Annual Product Quality Reviews (APQR) and collaborated with cross-functional teams to discuss trends and recommend improvements
- Supported regulatory audits (USFDA, WHO-GMP, EU-GMP) and maintained inspection readiness across operations
- Audit compliance and In process monitoring in Shop floor areas - From Granulation to end packing.
Education
M.Sc. - Biochemistry
Madras University
01.2018
B.Sc. - Biochemistry
Madras University
01.2016
Skills
- Review and approval of Batch Records
- Review and approval of analytical reports from QC
- Review and approval of cleaning validation reports
- GMP Documentation
- Continuous process verification
- Process capability analysis and optimization
- Statistical analysis of product & process Data - By Minitab
- Operational Excellence
- Cross-Functional Coordination
- Facilitate Communication
- Teamwork
- Process Improvements
Certification
Certified Six sigma Green Belt
Certified Minitab - Analyst
Languages
English
Tamil
Personal Information
- Date of Birth: 08/14/94
- Nationality: Indian
Disclaimer
I declare that the information provided is true to the best of my knowledge.
Additionalinformation
Experience in supporting internal audits and maintaining inspection readiness., QA oversight of site processes, including pest control programs and warehouse management.
Timeline
Senior Executive, Quality Assurance
Strides Pharma Science International Limited
04.2022 - Current
Junior Executive, Quality Assurance
Apex Laboratories Private Limited
12.2018 - 03.2022
Certified Six sigma Green Belt
Certified Minitab - Analyst
M.Sc. - Biochemistry
Madras University
B.Sc. - Biochemistry
Madras University
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