Rupinder Kaur
Summary
- Over 8 years in validation with expertise in Computer System Validation, SDLC, technical writing, and manual/automated testing in pharmaceutical and medical industries. Specialization in 21 CFR Part 210, 211, 820 compliances, GAMP, and GxP (GMP, GLP, GCP). Experience with enterprise systems like Siebel CRM, LIMS, CTMS, AERS, TrackWise, Inventory Management System, and Remedy. Comprehensive experience in full validation life cycle, including developing SDLC for validated systems, validation plans, IQ/OQ/PQ, RTM, and validation reports. Skilled in developing test strategies, test scripts, test cases, test plans, and managing testing artifacts using Quality Center. Conducted GAP analysis, developed CAPA plans, and prepared risk assessment, regulatory assessment, technical assessment, remediation plans, and deviation reports for FDA-regulated environments. Proficient in StarLIMS, SQL
- LIMS, Win Runner, Load Runner, Test Director, and LabWare LIMS. Developed and reviewed URS, FRS, and DS in compliance with FDA and MHRA regulations. Experience in utilities and facilities qualification, equipment qualification, and computer validation, including Factory Acceptance Test (FAT). Strong understanding of 21 CFR Part 11, 210, 211, 820, GAMP 5, and FDA, GCP/ICH guidelines. These points highlight your extensive experience and expertise in validation within the pharmaceutical and medical sectors.
Overview
8
8
years of professional experience
Work History
CQV Specialist
Edwards Lifescience
12.2022 - Current
- Part of a Qualification Team for biopharmaceutical equipment validation.
Validation Engineer
Teva Pharmaceuticals, PA
07.2020 - 11.2022
- Generated and executed validation protocols and summary reports.
Computer Systems Validation Engineer
Pfizer, Rocky Mount, NC
09.2018 - 06.2020
- Lead and conduct validation activities in compliance with US FDA 21 CFR Part 11 & 21 CFR Part 211.
Validation Engineer
SUN PHARMA, India
04.2016 - 03.2018
- Conducted comprehensive testing and validation activities, ensuring compliance with industry standards and regulatory requirements.
Education
Baba Banda Singh Bhadur Engineering College
INDIASkills
- Validation Deliverables
- Laboratory Equipment's
- Laboratory Equipment/CSV
- CSV (computer system validation)
- FDA Regulations
- Methodologies
- Tools
- Operating System
Timeline
CQV Specialist
Edwards Lifescience
12.2022 - Current
Validation Engineer
Teva Pharmaceuticals, PA
07.2020 - 11.2022
Computer Systems Validation Engineer
Pfizer, Rocky Mount, NC
09.2018 - 06.2020
Validation Engineer
SUN PHARMA, India
04.2016 - 03.2018
Baba Banda Singh Bhadur Engineering College
Similar Profiles
AWILDA ECHEVARRIAAWILDA ECHEVARRIA
MANUFACTURING CORDINATOR at EDWARDS LIFESCIENCEMANUFACTURING CORDINATOR at EDWARDS LIFESCIENCE
ANTHONY CARTERANTHONY CARTER
SR. CLINICAL IMPLANT SPECIALIST at EDWARDS LIFESCIENCESR. CLINICAL IMPLANT SPECIALIST at EDWARDS LIFESCIENCE
Rupinder KaurRupinder Kaur
CQV Specialist at Edwards LifescienceCQV Specialist at Edwards Lifescience
null null
QAV Specialist at BMQAV Specialist at BM
Abhinay JilukaraAbhinay Jilukara
SDLC Quality Engineer at Standard GroupsSDLC Quality Engineer at Standard Groups