Kavin .p

Achievement-driven Quality Professional with 2.4 years of experience seeking Opportunity in CSV, Quality Assurance & Compliance with a growth-oriented organization in pharmaceuticals and IT consulting firms.

QA EXECUTIVE - Bal Pharma Limited - Bangalore

(2025-04)

• Preparation Annual Product Quality Review (APQR) – Data Collections & Preparation of Reports
• Domestic Regulatory Affairs (DRA) – Data Collection, Preparation of Additional Product Application, Test Licence & Applying for NOC (Part1 & Part2)
• Handling of Change Control (CC)
• Internal Audits – Conducted internal audits to assess compliance with company policies, procedures, and regulatory requirements.
• Supported the implementation and maintenance of the Quality Management System (QMS) in compliance with organizational and regulatory requirements.
• Proficient in GxP, GAMP5, FDA & EU regulations, including 21 CFR Part 11, Annexure 11, and ICH Q9
• Developing and executing Risk Management Plans aligned with ICH Q9 to identify and mitigate potential risks
• Maintaining GxP computerized systems lifecycle, including re-evaluation, periodic review, change control, and deviation management
• Prepared and Executed Data Integrity Risk Assessment (DIRA) to Identify Potential Risks and Ensure Compliance with ALCOA++ Principles and Regulatory Requirements
• Handled Deviations and Discrepancies in CSV Activities by Performing Impact Assessment, Root Cause Analysis and Implementing Corrective and Preventive actions (CAPA) in Compliance with Gxp Requirements
• Performed Winlock Verification to ensure System Security Controls, User Access Restrictions, and Compliance with Data Integrity Requirements
• Performed Audit Trail Review Through HMI for Gxp Computerized Systems to Verify Data Integrity, Monitor User Activities and Ensure Compliance with ALCOA++ and 21 CFR part 11 Requirements
• Executed Performance Qualification (PQ) for Blender, Tablet Coating Equipment, Verifying Consistent Performance and Ensuring Compliance with Predefined Acceptance Criteria and GMP Requirements
• Performed Alarm Management System to Monitor, Review, and Ensure Proper Functioning of System Alarms in compliance with GMP Requirements
• Collaborated with QA, production, and engineering teams to execute cleaning validation using CLEEN software, improving efficiency and compliance
• Performed Decommissioning of Gxp Equipment (Leak test Apparatus and ERH Meter) in Accordance with approved Procedures, Ensuring Proper Data Archival and Regulatory Compliance

QA TRAINEE - Senses Pharmaceuticals Private Limited - Bangalore

(2024-04 - 2025-04)

• Performed in-process checks during Batch Manufacturing to Ensure compliance with Quality Standards
• Ensured Accurate Online Entries in Batch manufacturing records and Log Sheets.
• Performed Online Review and Compliance Verification of BMRs
• Implemented GMP Guidelines, Quality Systems, and Manufacturing Procedures Effectively
• Performed In-process Sampling as Per SOP Requirements
• Provided Line Clearance for Ongoing Manufacturing Operations in Accordance with SOP
• Collected Validation and QC Samples and Submitted them to QC Department for Analysis
• Monitored and Performed AQL Checks to Maintain Product Quality Standards
• Prepared AQL kits and Conducted Qualification of Visual Inspectors
• Performed Hold Time Study to Establish and verify Acceptable Holding time for Intermediate and bulk Products, Ensuring Product Quality and Compliance with GMP Requirements
• Executed process Validation Activities as Per Approved Protocols and Compiled detailed Process Validation Reports
• Prepared and Reviewed Validation Protocols, Reports, and Risk Assessment Documents
• Performed Cleaning Validation Activities Including Swab and Rinse Sampling as Per Approved procedures
• Monitored Critical Process Parameters (CPP) and Critical Quality Attributes (CQA) during Validation runs

Bachelor of Pharmacy - The Erode College of Pharmacy (2019 - 2023)