PRITI PATIL

• Managed and maintained electronic Trial Master File (eTMF) in Veeva Vault ensuring compliance with ICH-GCP, ALCOA+, and regulatory requirements.
• Performed document QC (Quality Control) checks to ensure accuracy, completeness, and adherence to TMF structure.
• Ensured inspection readiness of TMF by maintaining realtime document filing and resolving discrepancies.
• Coordinated with study teams, and stakeholders for document collection and query resolution.
• Raised, tracked, and resolved TMF queries within defined timelines.
• Acted as (Point of contact) POC and Subject matter expert for expedited document allocation, overseeing training materials and query list management, ensuring timely document distribution, tracking, and efficient query resolution across stakeholders.
• Supported audits and regulatory inspections by providing required documentation.
• Trained and mentored members on TMF processes, QC checks, and system usage.
• Monitored TMF metrics and KPIs (completeness, timeliness, QC cycle time) and contributed to continuous improvement initiatives.
• Verify metadata, correct TMF placement according to the TMF Reference Model.
• Managed remote access setup for new associates on client applications as an additional responsibility.

• Performed QC review of clinical study documents, method validation reports, and study reports to ensure compliance with quality and regulatory requirements.

• Worked on studies and projects submitted to USFDA and EMEA regulatory authorities.

• Utilized Laboratory Information Management System (LIMS) and SDMS for study data management (internal software).

• Conducted in-process quality review of laboratory activities related to bioanalytical studies and method validation.

• Reviewed study protocols, reports, and supporting documentation for accuracy, completeness, and regulatory compliance.

• Applied knowledge of ICH-GCP, GLP, and internal SOPs to ensure adherence to quality standards and regulatory guidelines.

• Assisted in addressing sponsor and regulatory authority queries by providing accurate documentation and quality-related support.

• Coordinated audit compliance activities, including document review, evidence compilation, audit preparation, and audit readiness.

• Assisted in developing and validating methods to enhance laboratory procedures.
• Calibrated analytical instruments to maintain accuracy and reliability in measurements.
• Calibration for laboratory instruments.
• Sample processing and analysis using analytical instruments.