Pallavi Jagtap

Dedicated QA Specialist with over 5+ years of experience in regulatory compliance and Quality Management Systems (QMS) within the clinical operations.Expert in managing Electronic Document Management Systems (EDMS), Veeva Vault and ensuring strict Document Control in accordance with ISO 13485, FDA Regulations, and HIPAA Compliance. Proven track record in streamlining complex quality metrics and maintaining inspection readiness through rigorous internal auditing and corrective actions.

eTMF Specialist at TATA CONSULTANCY SERVICES (TCS) (2022-07 – Present)

Manage end-to-end Document Control lifecycle within Electronic Document Management Systems (EDMS) ensuring strict regulatory compliance and Quality Management Systems (QMS) standards.

• Trend quality metrics and KPIs to identify performance gaps, leading Corrective and Preventive Actions (CAPA) and remediation training to ensure all documentation meets user requirements.
• Ensure TMF records are compliant with FDA Regulations, HIPAA Compliance, DIA Reference Model, and ICH GCP standards to maintain high product quality.
• Partner with cross-functional teams to support Internal Auditing and external inspections, resulting in zero critical findings and 100% audit readiness.
• Assist with the development of SOPs for Document Control and coordinate management activities across functional teams to improve workflow efficiency by 25%.

Lead Clinical Research Co-ordinator at CLINITHINK SERVICES PVT.LTD. (2020-09 – 2022-07)

Managed and supervised site teams across Phase II, III, and IV trials within a clinical laboratory environment to ensure adherence to ISO 13485 standards.

• Partnered with investigators to manage Nonconformance Reporting (NCR) and complex queries, performing SAE and third-party data reconciliations to ensure data integrity.
• Ensured site preparedness for Internal Auditing, monitoring visits, and regulatory inspections through proactive quality checks and investigator site file maintenance.
• Managed the Clinical Trial Management System (CTMS), trending site compliance scores and entering data in accordance with strict corporate Quality Management Systems.
• Assisted with database lock activities by ensuring all quality queries were resolved and finalized within Electronic Data Capture (EDC) systems.

Diploma in Advanced Clinical Research, Pharmacovigilance & Clinical Data Management – DYSMECH CLINICAL SERVICES (2020-01 – 2020-01)

M.Sc. in Organic Chemistry – SAVITRIBAI PHULE PUNE UNIVERSITY (2017-01 – 2017-01)