Kamini S

Detail-oriented QA Executive with 3 years of experience in pharmaceutical quality assurance, specializing in QA documentation, document management, audit support, Quality Management System (QMS) activities, and Computer System Validation (CSV). Experienced in ensuring GMP compliance, maintaining controlled documentation, supporting regulatory inspections, and validating computerized systems in accordance with GxP and 21 CFR Part 11 requirements.

QA Executive - Strides Pharma Science Limited

• Managed QA documentation in compliance with GMP, GDP, and company SOPs.
• Prepared, reviewed, issued, and archived controlled documents including SOPs, specifications, protocols, reports, and forms.
• Supported internal, customer, and USFDA audits by preparing documentation and addressing audit observations.
• Performed QMS activities including deviations, CAPA, change control, incident management, and document control.
• Worked with electronic quality systems such as DMS, DocPro, TrackWise, LIMS, and e-Log/e-Calibration systems.
• Assisted in validation of GxP computerized systems.
• Prepared and reviewed Validation Plans, User Requirement Specifications (URS), Functional Specifications (FS), Risk Assessments, IQ, OQ, PQ protocols, Traceability Matrix, Validation Reports, and SOPs.
• Supported execution of IQ, OQ, and PQ activities.
• Participated in change control and periodic review of validated systems.
• Ensured compliance with GAMP 5, 21 CFR Part 11, and applicable regulatory guidelines.
• Maintained validation documentation throughout the system lifecycle.

Bachelor of Technology (B.Tech) - Information Technology