Lakshmidurga Vemuri

Quality Assurance and Validation Specialist with 8 years of experience supporting pharmaceutical, biotechnology, and medical device organizations across Asia and global regulated environments. Experienced in Quality Management Systems (QMS), Computer System Validation (CSV), batch record review, GMP documentation, deviation and CAPA management, data integrity, and regulatory compliance. Proven track record of supporting FDA, EU Annex 11, GAMP 5, and other GxP requirements while ensuring inspection readiness and maintaining validated systems.

Following my relocation to the United States, I experienced a career break due to H4-EAD work authorization requirements. During this period, I remained professionally active by enhancing my skills in Clinical SAS, Microsoft Power BI, data analytics, GMP regulations, data integrity, and pharmaceutical quality systems. This period allowed me to strengthen both my technical and compliance knowledge while preparing to re-enter the workforce upon receiving work authorization.

Senior QA & Validation Specialist at Edward Life Sciences (2020-03 – 2021-07)

• Led QA oversight of CSV deliverables for GxP-relevant systems including EDMS, LMS, and lab informatics tools; reviewed and approved URS, Risk Assessments, IQ, OQ, PQ, and Traceability Matrices per GAMP 5 and Annex 11.
• Administered LMS compliance by assigning curricula, tracking overdue training, and preparing training reports to support internal audits, FDA inspections, and Notified Body reviews.
• Supported global document harmonization initiatives across company divisions to standardize procedures, templates, and training structures under a unified QMS framework.
• Reviewed and approved change controls, CAPAs, deviations, and non-conformances in TrackWise, ensuring thorough QA risk assessments and timely closure with effective corrective actions.
• Served as QA lead for periodic reviews of validated systems, ensuring systems maintained their validated state and were compliant with Data Integrity principles and ALCOA+ standards.
• Participated in the implementation and validation of new GxP systems, including LMS upgrades and EDMS migrations; supported configuration, test protocol review, and user access validation.
• Acted as liaison between QA, IT, Regulatory, and Engineering teams to ensure that quality and compliance requirements were embedded in system design and procedural controls.
• Prepared inspection-ready document packages including training logs, change control histories, and validation documentation during FDA, ISO, and MDSAP audits.
• Authored and maintained QA procedures governing documentation control, computer validation, electronic signatures, audit trail reviews, and data governance.
• Led data integrity audits and supported remediation efforts across documentation and training systems, ensuring compliance with FDA Data Integrity Guidance and internal quality policies.
• Conducted QA training sessions for cross-functional teams on procedural updates, validation best practices, and GxP documentation handling for medical device systems.
• Supported CAPA effectiveness checks and management review inputs by preparing metrics related to document cycle times, training compliance, validation deliverables, and audit findings.

Sr.QA Executive - CSV at S.M Pharmaceuticals (2016-02 – 2018-12)

• Led quality risk assessment initiatives using FMEA tools to evaluate and mitigate process deviations and equipment-related nonconformities.
• Reviewed manufacturing and validation documentation to verify compliance with cGMP requirements and data integrity principles prior to QA approval.
• Supported investigation and resolution of documentation discrepancies, deviations, and non-conformances impacting production and batch release timelines.
• Supported internal and external audits by ensuring document readiness, coordinating audit responses, and following up on corrective actions for compliance gaps.
• Reviewed and standardized Standard Operating Procedures (SOPs) and quality documents to ensure alignment with cGMP, GDP, and 21 CFR Part 11 requirements.
• Delivered training sessions on updated procedures, quality documentation practices, and compliance expectations; facilitated cross-functional coordination with Manufacturing, Packaging, Engineering, and R&D teams.
• Reviewed FAT, SAT, and validation protocols (IQ, OQ, PQ), along with specification documents (URS, FRS), test plans, and project documentation for new equipment, utilities, and computerized systems.
• Oversaw validation and qualification activities related to manufacturing equipment, packaging systems, formulation processes, and facility utilities, ensuring compliance with internal QA standards and regulatory guidelines.
• Reviewed and approved qualification and requalification protocols for equipment and systems supporting both Oral Solid Dosage (OSD) and Sterile Injectable manufacturing.
• Participated in root cause analysis (RCA) of production deviations and supported implementation and tracking of corrective and preventive actions (CAPAs) in alignment with QMS requirements.
• Reviewed Validation Master Plans (VMP) and Validation Summary Reports (VSR) to ensure traceability, risk management alignment, and audit readiness.
• Verified and approved commissioning and qualification documentation for facility systems, including HVAC, purified water, and compressed air, as part of QA oversight.
• Ensured validation lifecycle documentation and change control records adhered to Good Documentation Practices (GDP) and 21 CFR Part 11 electronic recordkeeping standards.
• Collaborated with technical and production teams to troubleshoot process deviations and ensured QA oversight of issue resolution activities.
• Reviewed and maintained Requirements Traceability Matrices (RTMs) to confirm that user requirements were adequately mapped to design specifications and validated through appropriate testing.

Career Break (2021-01 – 2025-01)

Relocated to the United States and awaited H4-EAD work authorization. Utilized the period for professional development, Skill enhancement such as learning Clinical SAS, Power BI, new GMP/CSV knowledge enhancement, regulatory training, and maintaining expertise in pharmaceutical quality systems.

Masters in Quality Assurance