Sai Krishna Vinjam

Quality Control Analyst

HETERO PHARMACEUTICALS

05.2018 - 06.2021

Demonstrated expertise in understanding and implementing FDA regulations, particularly CFR Title 21, with a primary focus on pharmaceuticals.
Ensured strict adherence to Good Manufacturing Practices (GMP) standards and FDA regulations within manufacturing processes, resulting in consistently high product quality and safety.
Maintained meticulous records of production activities and compliance documentation to ensure transparency and accountability throughout the manufacturing process.
Successfully managed Change Control & Deviation Management processes while ensuring full compliance.
Proficiently identified and mitigated production risks through effective Risk Management practices.
Ensured Cleanroom & Facility Compliance, maintaining GMP-compliant facilities.
Extensive experience in Root Cause Analysis (RCA) for Out of Specification (OOS) and Out of Trend (OOT) results.
Proactively implemented Continuous Improvement measures to reduce OOS and OOT occurrences.
Developed and executed CAPA plans based on RCA findings, leading to improved processes.
Provided Case Studies showcasing successful problem-solving and contributions to RCA efforts.
Proficiently troubleshooted equipment and process issues, conducting Risk Assessments and implementing resolutions.
Expertly handled regulatory-compliant documentation, aligning with FDA and GMP standards.
Conducted testing and analysis of raw materials, intermediates, and finished pharmaceuticals to ensure compliance with standards.
Ensured thorough QC testing and review before market release through Batch Release processes, guaranteeing safety, efficacy, and consistency.
Conducted laboratory testing, including chemical, physical, and microbiological tests, to assess attributes like purity, potency, and sterility.
Monitored critical parameters during production through In-Process Monitoring to stay within specified limits.
Maintained comprehensive record-keeping to trace and document manufacturing and testing steps.
Ensured regulatory compliance with FDA and global regulatory standards for safety and efficacy.
Handled Out of Specification (OOS) cases, investigating and addressing deviations using processes like RCA and CAPA.
Developed and maintained standardized Standard Operating Procedures (SOPs) for all processes.
Expertise in Risk Management for identifying and mitigating risks in drug development and manufacturing.
Proficiency in cleaning validation processes for pharmaceutical and manufacturing environments, aligning with FDA cGMP regulations.
Designed and executed cleaning validation protocols, including worst-case scenarios.
Oversaw analytical testing, residue analysis, and preparation of validation reports.
Collaborated on equipment qualification and change control management.
Ensured data integrity throughout the cleaning validation process, implementing comprehensive data integrity measures.
Integrated data integrity principles into the quality management system.
Led the development and implementation of SOPs for data integrity controls.
Managed electronic records and audit trail functionalities effectively.
Conducted training and workshops on data integrity principles and implemented continuous data monitoring and backup procedures.
Managed change control processes related to data integrity controls.
Proficiently ensured compliance with Current Good Manufacturing Practices (cGMP) regulations for pharmaceuticals, biologics, and medical devices.
Successfully managed equipment calibration processes to ensure accuracy and reliability.
Conducted rigorous testing and quality checks on incoming raw materials, maintaining the highest standards of quality and compliance in the manufacturing process.
Demonstrated expertise in validating manufacturing processes to ensure product quality.
Expertise in extensive batch record management.
Ensured compliance with regulatory packaging and labeling standards for labeling and packaging.
Implemented Data Integrity Practices to ensure data accuracy and compliance in record-keeping and data management.
Proficient in the creation and approval of SOPs, risk assessments, test plans, and validation processes.
Ensured pharmaceutical process consistency and compliance throughout the tenure.