Maancy Negi
Noida
Summary
Highly skilled CSV Consultant and QA with 3 years of experience in ensuring compliance with regulatory guidelines and industry standards, proven track records of successfully managing and executing multiple project simultaneously. Seeking a challenge role where I can leverage my expertise to drive quality and efficiency in software development processes,.
Overview
4
4
years of professional experience
Work History
Associate Quality Analyst
RxLogix Corporation
09.2022 - Current
- Understanding of implementing project on SaaS Models
- Interacting with internal product owners and client users to understand business, functional and non-functional requirements, or improvements for software product, Review, understand and ensure that the requirements are detailed, un-ambiguous, complete and testable.
- Spearheaded and managed all CSV activities in multiple client implementation project and internal product releases concurrently.
- Reviewed and approved various validation deliverables, including change requests, Requirement/Stories in JIRA, Validation Test Plans, Design Specification, 21 CFR Part 11Assessments, Testing Protocols (IQ/OQ/PQ) using X-Ray, Defects, Requirements Traceability Matrix, Validation Test Summary Reports, Release Notes, Software Release Authorization Forms and emergency Release Authorization Forms.
- Provide adequate understanding and expertise on Change Control Procedure, Deviation Handling, Document Management and CAPA management.
- In Depth understanding of 21 CFR Part 11, EU Annex 11 compliance.
- Coordinate/Co-Author the revision, review, and approval of IT SOPs and other GxP documents.
- Conducted multiple organization-wide sessions on GDP and GTP for freshers.
- Understanding and Reviewing pf the bugs and associated Root cause (5 whys analysis)
- Drive continuous improvement efforts initiatives to establish an effective Quality Management System (QMS) wrt Engineering and Professional services for RxLogix
- Support in making changes to the QMS and working with function heads to coordinate process creation, template
- successfully worked as Project Manager in ZenQMS for multiple releases.
- Dept knowledge GAMP, GDP,GXP, FDA, EU regulation
- Creations and updates to existing processes/templates
- Participate in external audits/assessments
- Ensure smooth conduct of internal audits and timely address of internal commitments.
Healthcare Recruiter
Cambay Consulting
11.2021 - 09.2022
- Delivers organization's hiring plan by finding candidates for open positions proactively or reactively by performing full-cycle recruiting functions including job understanding, candidate sourcing, social networking, phone screening, email communication, documentation, summary writing and presentation.
Clinical Research Coordinator
GastroLab Pvt. Ltd
08.2021 - 11.2021
- In Gastroenterology department
- Lead the coordination and execution of clinical trials for investigational medical device ensuring adherence to protocol and Regulatory Compliance
- Cooperate with principal investigators to develop research objectives, study protocols and data collection strategies
- Successfully enroll and manage a diverse patient cohort.
Project Trainee
Auriga Research
01.2021 - 07.2021
- Auriga Research is CRO offering Pharmacovigilance and
- Clinical Trials Service for Drugs, Device, Vaccine and cosmetics
- Worked in every project maintaining roles and responsibility of Clinical Research Coordinator.
Education
MS/M.Sc - Science, Research
Swami Rama Himalayan University
2021
B.Sc - Biology
College Hemwati Nandan Bahuguna GarhwalUniversity
2019
Skills
- Well Versed With Pharmacovigilance
- Concepts And Reporting Guidelines (FDA ICH, EMEA And Other International Guidelines)
- Understanding Of Drug Development Process including Drug Safety And Different Phases Of Clinical Trial
- Knowledge Of Case Triage, Labeling/Listed And Causality Determination
- SDLC, Computer System Validation And GAMP Guidelines
- Technical Skills: MS Office Word, Excel, Regulatory Affairs, GDP, JIRA, SaaS models, ALCOA
- Language Known: Hindi, English
Accomplishments
- Spot Award at current emoloyment.
Timeline
Associate Quality Analyst
RxLogix Corporation
09.2022 - Current
Healthcare Recruiter
Cambay Consulting
11.2021 - 09.2022
Clinical Research Coordinator
GastroLab Pvt. Ltd
08.2021 - 11.2021
Project Trainee
Auriga Research
01.2021 - 07.2021
B.Sc - Biology
College Hemwati Nandan Bahuguna GarhwalUniversity
MS/M.Sc - Science, Research
Swami Rama Himalayan University
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