KOUSHIK REDDY MATTA
Lee,MA
Summary
As a Formulation Associate and QA validation specialist and process engineer with more than 2 years of experience in the Pharmaceutical industry, I have developed a strong understanding of formulation techniques, quality assurance, validation protocols, and process engineering principles. I have actively participated in designing and implementing validation protocols, conducting risk assessments, and performing validation testing. In my role, I have also collaborated with production teams to monitor process performance, identify, and resolve issues, and drive continuous improvement. I have demonstrated the ability to document formulation and validation activities, maintain accurate records, and communicate effectively with stakeholders at various levels.
Overview
4
4
years of professional experience
1
1
Certification
Work History
FORMULATION ASSOCIATE II
BERKSHIRE STERILE MANUFACTURING
LEE, MA
05.2023 - Current
- Prepare buffers, media, and solutions essential for formulation processes, demonstrating precision in measuring and mixing ingredients to meet specified standards.
- Utilize various process equipment, including tanks, filtration devices, and integrity testing tools, to facilitate smooth operation and efficient production processes while adhering to established Standard Operating Procedures (SOPs) and safety protocols.
- Execute daily formulation tasks with precision, including the setup of laboratory equipment, conducting in-process testing, and monitoring Active Pharmaceutical Ingredient (API) dissolution.
- Thoroughly document formulation activities by accurately completing Batch Records, ensuring compliance with regulatory guidelines and internal quality standards.
- Proactively identify and address deviations in the formulation process, authoring detailed reports and participating in investigations to implement corrective and preventative actions, thereby minimizing risks of product loss or non-compliance.
- Operate and maintain glass washers and autoclaves to ensure proper cleaning and sterilization of equipment, maintaining compliance with Good Manufacturing Practices (GMP) standards.
- Maintain strict adherence to all area SOPs, diligently completing logbooks and documentation to uphold cGMP requirements and ensure compliance with FDA regulations, including 21 CFR 820 and 21 CFR 210/211.
QA Validation Specialist
ITC PVT LTD
Bhadrachalam, Telangana
02.2021 - 08.2021
- Facilitated external audits from certification bodies and regulatory agencies, resulting in successful ISO 9001 and ISO 17025 certifications
- Developed and implemented audit plans and schedules, ensuring timely and effective assessment of quality management systems
- Demonstrated ability to collaborate with cross-functional teams to coordinate and execute IQ/PQ/OQ testing, ensuring adherence to project timelines and regulatory requirements
- Understanding of 21 CFR Part 210 and 211 regulations and their application in the pharmaceutical industry
- Knowledge of current good manufacturing practices (cGMP) and quality control principles
- Participated in internal and external audits, providing necessary documentation, and addressing audit findings
- Utilized CQMS to manage and track corrective and preventive actions (CAPAs), driving timely resolutions to quality issues and reducing non-conformities
- Developed and maintained standard operating procedures (SOPs) for CQMS usage, ensuring consistent and compliant use throughout the organization
- Acted as a subject matter expert on CQMS during external audits, supporting auditors with data and system demonstrations.
Process Engineer
Nagarjuna Fertilizers and Chemicals Limited
India
06.2020 - 01.2021
- Analyze existing production processes and identify areas for improvement to enhance efficiency, productivity, and quality in fertilizer manufacturing
- Develop and design efficient and effective processes for fertilizer production, including material handling, reaction kinetics, heat and mass transfer, and process equipment selection
- Perform material and energy balance calculations to ensure optimal utilization of raw materials, energy sources, and utilities in fertilizer production
- Implement and adhere to safety protocols and regulatory requirements, ensuring a safe working environment and compliance with relevant standards (e.g., Process Safety Management, Hazard, and Operability Studies)
- Ensure compliance with environmental regulations related to air emissions, wastewater management, waste disposal, and sustainable practices in the fertilizer production process.
Education
Master of Science - Biomedical Engineering
University of South Florida
05.2023
Bachelor of Science - Chemical Engineering
Osmania University
05.2020
Skills
- Quality assurance and validation
- Cleaning validation
- Root cause analysis
- Regulatory compliance
- Quality control procedures
- Cross-functional collaboration
- Communication
- Equipment qualification
- Process skills
- Problem-solving
- Validation
- Quality Control Management
Projects
The Laboratory Management System using PHP and MySQL, The Laboratory Management System PHP and MySQL project is a web-based project that was created in PHP and MySQL. Using this project, we can handle View, Update, Student, Report, Lab, and Complete Information. To eliminate manual errors and create a computerized system, the Laboratory Management System PHP and My SQL Project's primary goal. Various types of modules are provided in this project to control Lab, Update, and View. For Update, View, Report, and Complete Information, we can also generate reports.
Certification
- Lean Six Sigma
- Hazardous Waste and Handling Labs
- Laboratory and Research safety: Comparative Medicine
- Biomedical Waste Safety Training
- EHS Laboratory Safety-Chem/Bio
Timeline
FORMULATION ASSOCIATE II
BERKSHIRE STERILE MANUFACTURING
05.2023 - Current
QA Validation Specialist
ITC PVT LTD
02.2021 - 08.2021
Process Engineer
Nagarjuna Fertilizers and Chemicals Limited
06.2020 - 01.2021
Master of Science - Biomedical Engineering
University of South Florida
Bachelor of Science - Chemical Engineering
Osmania University
- Lean Six Sigma
- Hazardous Waste and Handling Labs
- Laboratory and Research safety: Comparative Medicine
- Biomedical Waste Safety Training
- EHS Laboratory Safety-Chem/Bio
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