Kusum Rawat
Bangalore
Summary
Dedicated professional with a strong work ethic and exceptional interpersonal skills, recognized for the ability to quickly adapt to new challenges. Proven track record of mastering new skills independently and delivering results in fast-paced environments. Core competencies include effective communication, problem-solving, and time management. Seeking opportunities to leverage these strengths in a dynamic organization.
Overview
8
8
years of professional experience
Work History
SOP/CAPA/Deviation Manager
Tata Consultancy Services
Mumbai
04.2019 - Current
- Collaborate with CAPA & Deviation Functional Heads in effective closures of PV related Audit findings/QEs
- Engage with Functional Heads for effective maintenance and tracking of CAPAs/Deviations/QE’s
- Contribute to CAPA/Deviation Management implementation and documentation of quality nonconformance by completing all required processes
- Hands-on experience in TrackWise database for management of PV CAPA & Deviations/QE’s
- Support the continuing development and implementation of a process for managing and tracking PV Global SOPs
- Collaborate with Functional Heads in facilitation of investigation & root cause analysis
- Work with GPV Training team to ensure their awareness of global PV SOP releases and to ensure that applicable training is rolled out as required
- Generate and publish monthly compliance dashboard detailing deliverables related to Global PV SOPs, CAPAs and Deviations/QE’s
- Assist the internal QA team in managing the audit and inspection document requests related to CAPA & Deviations
- Support the Global QPPV office in managing the PSMF in line with the relevant Client processes by quality check of assigned PSMF Quality sections & respective annexes
- As a cross-collaboration skill program getting trained on Argus Safety Database
- Topics covered are -Software Development Life Cycle (SDLC) and Computer System Validation (CSV) procedures, User story in JIRA, Installation Qualification (IQ), Operational Qualification (OQ), User Acceptance Testing (UAT) scripts of safety system changes in 'Application Lifecycle Management' tool
Pharmacovigilance Officer
Wipro Ltd.
New Delhi
08.2016 - 04.2019
- Overall 3 years of experience as Subject Matter Expert in ICSR process
- Perform daily ICSR and source data review of expedited ICSR cases
- Coordinate with internal stakeholders for process related Deviations & CAPAs
- Act as a POC for process related internal audits
- Exchange of documents and notification to Licensing Partners/other company as per PV agreements
- Support internal quality improvement activities
Education
M. Pharm. - Clinical Pharmacy
Shri Guru Ram Rai Institute of Technology & Science
Dehradun, India01.2016
B. Pharm. -
Shri Guru Ram Rai Institute of Technology & Science
Dehradun, India01.2014
Skills
- CAPAs & Deviations/Quality Events Management & Tracking
- ICSR Processing
- Knowledge of Pharmacovigilance Aggregate Reporting
- PV SOP project management
- IQMS Audits
- Project Audit readiness
- Veeva Vault
- PSMF update
- Process Improvement
- 21 CFR Part 11
- Argus Safety
- Agile Project Management
- ServiceNow
- Application Lifecycle Management (ALM)
- Software Development Life Cycle (SDLC)
- Change Management
- Computer System Validation (CSV)
- Microsoft Excel
- Advanced Microsoft Excel
- Time management abilities
- Multitasking
- Problem-solving abilities
Languages
- English
- Hindi
Personal Information
- Date of Birth: 03/11/93
- Marital Status: Married
Mobilenumbers
- 08126060117
- 09650357557
Timeline
SOP/CAPA/Deviation Manager
Tata Consultancy Services
04.2019 - Current
Pharmacovigilance Officer
Wipro Ltd.
08.2016 - 04.2019
M. Pharm. - Clinical Pharmacy
Shri Guru Ram Rai Institute of Technology & Science
B. Pharm. -
Shri Guru Ram Rai Institute of Technology & Science
Similar Profiles
Vrunda ChindhadeVrunda Chindhade
HR Manager at Tata Consultancy Services, TCS, Tata Consultancy Services LimitedHR Manager at Tata Consultancy Services, TCS, Tata Consultancy Services Limited
Sreya BasuSreya Basu
Procare Analyst at Tata Steel(Tata Consultancy Services)Procare Analyst at Tata Steel(Tata Consultancy Services)
Arun VArun V
Program Manager at Tata consultancy services | Financial Ombudsman ServicesProgram Manager at Tata consultancy services | Financial Ombudsman Services