Sindhu Ganta

Quality Assurance Validation Manager with 10+ years of pharmaceutical and biotechnology experience leading validation, qualification, compliance, and inspection readiness programs in GMP-regulated environments. Expertise in Equipment, Process, HVAC and Computer System Validation, Risk Management, CAPA, Change Control, Data Integrity, 21 CFR Part 11, Annex 11, and Quality Management Systems (QMS). Proven success driving FDA and EMA inspection readiness, managing validation lifecycle activities, leading cross-functional teams, and implementing compliant validation strategies that improve operational performance and regulatory compliance.

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.

Master of Science - Industrial Pharmacy - LIU Brooklyn

Bachelor of Pharmacy - KLE College (RGUHS)