Shipra S

A diligent Quality Assurance professional with 14+ years of experience in Pharmacovigilance (PV) across core pharma and service industries. Currently working with Tata Consultancy Services (TCS) as PV Audit & Inspection Specialist for an innovator where I am responsible for conducting internal and external GVP audits, managing CAPAs, Deviations and ensuring inspection readiness. Prior to TCS, I was working with Sun Pharmaceuticals Industries Ltd and Wipro in capacity of Pharmacovigilance Quality Assurance Lead.

I am sincere, self-motivated, and a keen observer. I work with integrity and respect organizational values.

Pharmacovigilance Audit-Inspection & CAPA-Deviation Manager at Tata Consultancy Services (TCS) (2021-08 – Present)

• Audit & Inspection Readiness Toolkit: Authored Storyboards, Laptop usage guidelines in front room, PDF Redaction guidance, Handbook for pre-document response preparation, Audit/Inspection document request trackers, Readiness training material, Roles & Responsibilities trackers, timeline charters.
• Audits: Led execution of GVP audits, including, affiliate, business partner, process, service provider and CSV audits.
• Inspection Management: Served as back-room lead for health authority inspections (BfArM, FAMHP, EDA, and MFDS) ensuring data requests were fulfilled within provided timelines.
• SME Training: Coached 20+ Drug Safety Physicians and Scientists on Dos & Don'ts and "How to Interview" with inspectors, significantly reducing the risk of inconsistent verbal testimony.
• Global Harmonization: Standardized the List of procedural documents across affiliates improving consistent audit/inspection responses.
• CAPA & Deviation Management: Managed complete life-cycle of PV CAPA and Deviation process, including investigation, RCA, corrective action, implementation and effectiveness checks. Reduced overdue CAPAs.
• Health Authority (HA) Risk-assessment Questionnaire & Australian Pharmacovigilance System Summary (APSS): Authored Quality Management related sections and monitored overall completion of HA questionnaires (Dutch Health & Youth Care Inspectorate, TGA) and APSS.
• Operational Excellence: Successfully project managed validation of all the excel spreadsheets used for the client.
• Project Management Tools: Designed and maintained Defect log, FMEA, SIPOC, RACI matrix, Control Chart, Performance Prediction Model and Project Health Monitor.
• Record-Keeping: Upkeep of all audit/inspection records on SharePoint.

Pharmacovigilance QA Manager at Sun Pharmaceuticals Industries Ltd (2017-01 – 2021-12)

• Audits & Inspections: Conduct and participate in PV regulatory authority inspections, internal and business partner audits. Assist with audit and inspection readiness activities as well as facilitate audit reports closure.
• Deviation Tracking: Maintained deviation tracker.
• Root Cause Analysis (RCA): Trained colleagues across globe on how to do root cause analysis using scientific methods like "5 Ys" thereby bringing significant improvement in RCA.
• Corrective & Preventive Action (CAPA): Developed and monitored effectiveness check for CAPA plans.
• SOP Compliance Monitoring: Reinforced PV quality management system by authoring & revising SOPs based on GDPR requirements and monitoring gamut of compliance action items derived from various SOPs and procedural guidelines.
• Quality Metrics (QM): Performed QM reviews of sample ICSRs, Products & Licenses and expedited reporting rules configured in Argus Safety followed by top defect analysis and error-trending. Published monthly quality status reports/dashboards.
• SDEA Compliance Assurance: Improved SDEA compliance by developing QC checklist. Monitored safety data exchange reconciliation compliance with business partners and maintained global SDEA trackers.
• Quality Improvement: Standardized the otherwise varied case processing practices followed across various locations of Sun Pharma. Minimized deviations by revamping SOP revision system. Organized focused group discussions, knowledge sharing sessions (Twenty Minutes Training).

Quality Assurance Lead Pharmacovigilance at Wipro (2015-01 – 2017-12)

• Document Management: Authoring, proof reading, periodic reviewing, training and distribution of Standard Operating Procedures (SOP), Quality Management Plan (QMP) and other reference documents for the project.
• Compliance Oversight: Preparation of non-compliance report, deviation, RCA and CAPA development and implementation, Top Defect Analysis, Action Plans creation. Tracking all customer deliverables and driving closure.
• Governance Meetings: Led periodic quality review meetings and prepared business review/other review decks for the client.
• Client Visit: Hosted periodic client visits.
• Project Metrics: Oversight and publishing all critical project metrics.
• Customer Satisfaction (CSAT): Random internal audits, identified and led quality improvement initiatives for the project.
• Continuous Learning: Foster and maintain continuous learning environment.

Pharmacovigilance Associate at Wipro (2012-01 – 2014-12)

• Quality Check (QC): of ICSRs in ARGUS, percolate latest updates to the team for maintaining quality standards. Coach, mentor and provide feedback to peers and new hires when they are in their On-the-Job training.
• Case Processing: Duplicate case search, Triage, validity seriousness assessment, data entry, Narrative writing, and Literature case processing.

M. Pharm (Hons.) in Pharmacy – NIET, Greater Noida, Mahamaya Technical University (2012)

B. Pharm in Pharmacy – IIMT, Greater Noida, Gautam Budh Technical University (2010)

Level B1 in French language – Alliance Française de Delhi