Quality Assurance Validation Manager - PFIZER - North Carolina
(2025-01)
Developed and implemented quality and compliance strategies with senior leadership to achieve measurable compliance improvements and regulatory alignment.
- Led cross-site AI validation planning for manufacturing equipment, reducing project delays and closing validation gaps across global deployments.
- Managed validation projects involving equipment qualification, HVAC validation, and process validation using GMP principles while maintaining full lifecycle documentation and traceability.
- Oversaw risk assessments and implemented CAPA activities to strengthen validation reliability and system controls.
- Served as Quality Validation Subject Matter Expert (SME) for Change Control, validation governance, and inspection readiness initiatives.
- Reviewed and approved validation documentation for facilities, equipment, and manufacturing processes to ensure compliance with corporate and global requirements.
- Maintained audit readiness through document control, training, and validation lifecycle management.
- Coordinated root cause investigations for validation deviations and implemented corrective actions using PDOCs and Kneat systems to reduce recurrence.
- Participated in and approved FMEA-based risk assessments on manufacturing processes to prioritize validation activities and reduce compliance gaps.
Senior Quality Assurance Validation Specialist - Eurofins LANCASTER LABORATORIES - North Carolina
(2022-01 - 2024-12)
Led validation programs for equipment, manufacturing processes, and quality systems, improving process stability and documentation accuracy.
- Site lean lead with project coordination and project documentation reviews and technical clarifications supporting lean project approvals.
- Managed qualification protocols, risk assessments, traceability matrices, and validation documentation to sustain regulatory compliance and inspection readiness.
- Collaborated with cross-functional teams to align project schedules with regulatory milestones, ensuring timely delivery of validation projects.
- Reviewed vendor documentation, SOPs, and traceability matrices to verify Computer System Validation (CSV) compliance.
- Facilitated training programs and audit preparation activities supporting FDA and EMA inspections.
- Conducted investigations of out-of-specification laboratory results and reported the findings.
- Reviewed product stability studies and verified that test conditions were appropriate.
- Provided technical support during audits by regulatory agencies such as FDA.
QA Validation Specialist - BRISTOL MYERS SQUIBB - New Jersey
(2020-10 - 2021-12)
Acted as GMP manufacturing and validation SME while developing targeted training programs to improve team competency and compliance awareness.
- Investigated non-conformances, deviations, and complaints while implementing CAPA actions that reduced recurring quality issues.
- Trained team members on QTS, Veeva Vault, EAMS, and Electronic Batch Record (EBR) processes to improve documentation accuracy and compliance.
- Coordinated vendor documentation reviews and documented technical clarifications supporting approvals.
- Validated manufacturing processes, equipment, and Quality Control systems while ensuring documentation met regulatory requirements.
- Standardized validation templates and procedures to improve consistency, efficiency, and quality of validation documentation.
QA Validation Engineer - NOVO NORDISK PHARMACEUTICAL - North Carolina
(2019-09 - 2020-09)
- Conducted risk assessments and managed qualification protocols to maintain regulatory compliance.
- Coordinated requalification of GMP equipment and controlled storage environments to improve operational performance.
- Conducted commissioning and qualification activities, including temperature mapping studies for controlled storage environments.
- Resolved validation deviations through CAPA investigations and closure of quality records in TrackWise.
- Executed IQ/OQ protocols and documented results against predefined acceptance criteria to support product quality and compliance.
- Validated equipment and controlled storage environments through documented qualification protocols and acceptance criteria.
- Coordinated with maintenance teams to monitor equipment status and schedule requalification activities.
Validation Engineer - KITE PHARMA - Maryland
(2018-12 - 2019-08)
- Authored Validation Master Plans (VMPs), User Requirements Specifications (URS), Functional Requirements Specifications (FRS), risk assessments, and gap analyses.
- Created IQ/OQ/PQ protocols for CTUs and organized cross-functional meetings to gather user requirements and resolve technical issues affecting validation timelines.
- Commissioned and qualified laboratory and analytical equipment to meet GMP and regulatory standards.
- Conducted temperature mapping studies and prepared comprehensive validation summary reports.
- Authored qualification protocols for biosafety cabinets and ventilated workstations.
- Reviewed vendor documentation to align equipment practices with industry best practices and compliance requirements.
- Planned and scheduled equipment requalification activities to minimize downtime across manufacturing and QC laboratories.
Validation Engineer - UNITED PHARMA TECHNOLOGIES - New Jersey
(2018-02 - 2018-11)
- Documented project activities and closed tasks on schedule, producing records and measurable compliance outcomes.
- Maintained reports with strict version control and traceability to ensure regulatory adherence.
- Coordinated cross-functional reviews to identify and remove documentation gaps, reducing rework cycles and improving efficiency.
- Configured system templates to clarify reviewer responsibilities and shorten document rework timelines, increasing review throughput.
- Drafted deviation reports, plans, and acceptance rationale to support quality assurance release decisions.
- Reviewed calibration certificates and preventive maintenance records to ensure equipment accuracy and regulatory compliance.
Validation Engineer - BIOXCELL LIFE SCIENCES PVT. LTD. - Hyderabad
(2013-02 - 2014-12)
- Documented project activities and maintained validation records with strict version control and traceability.
- Drafted deviation reports, validation plans, and acceptance rationale supporting Quality Assurance release decisions.
- Executed validation protocols and temperature mapping studies for GMP equipment.
- Provided technical support for manufacturing equipment validation and operational readiness initiatives.
- Revised SOPs, test methods, and specifications to align with regulatory requirements.
- Maintained traceability matrices and conducted gap analyses for analytical systems.
- Evaluated GxP documentation and approved deviation notifications and corrective actions.
- Assembled validation binders in Veeva Vault, including final reports and signature packages for Quality / Regulatory review.
