Documentation And Business Analyst | Consultant@ Novartis
New York, New York, United States
Rani Maloney
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Rutgers University
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FlashIntel GPTRani Maloney is an experienced Quality Assurance professional with 15 years of experience in establishing effective Quality Assurance/Compliance practices and departments for FDA regulated environments. She has expertise in developing programs to ensure compliance with FDA regulations, collaborating with internal departments, and identifying root causes and implementing effective corrective/preventive actions. Rani has worked at Novartis as a Documentation and Business Analyst, RE/MAX as a Realtor, and as a Manager Regulatory Compliance and Quality Management. She also has experience as a Quality Auditor and a Sales Associate at GE. Rani is based in the United States.
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About
Experienced Quality Assurance professional with 15 years experience in Quality/Compliance, including establishing effective Quality Assurance/Compliance Practices and departments for FDA regulated environments. Relevant experience includes: * Developing programs to ensure compliance with FDA regulations * GxP and auditor training * Collaborating with internal departments to ensure on-going compliance * Establishing internal monitoring programs to track and trend errors and CAPAs * Identifying root cause and implementing effective corrective/preventive actions * Hosting sponsor audits and monitoring visits * Developing Pre-Approval Inspection (PAI) preparedness plans * Ensuring computer system validation compliance with 21 CFR Part 11 * Establishing and conducting internal and external audit program
...See MoreWork Experience
Documentation And Business Analyst | Consultant
Pharmaceutical Manufacturing
Rani Maloney's Professional Milestones
- Documentation And Business Analyst | Consultant (2015-08-01~): Streamlined documentation processes, ensuring accuracy and efficiency in business analysis.
- Realtor (2013-08-01~2015-08-01): Successfully negotiated and closed multiple high-value real estate deals, demonstrating exceptional real estate business expertise.
Education
Public Health
1997-1997Skill
Gcp
Fda
Gmp
Auditing
Iso
Gdp
Management
Validation
Capa
Pre Approval Inspection
Document Control
Sop
Project Management
Change Control
21 Cfr Part 11
Quality Assurance
Compliance
Computer System Validation
Internal Audit
Inspection
Quality Systems
Document Management
Drug Development
Ich Gcp
Quality System
Clinical Trials
Pharmaceutical Industry
Protocol
Quality Management
Software Documentation
Regulatory Submissions
Quality Auditing
Gxp
Regulatory Affairs
Regulatory Requirements
Lims
Standard Operating Procedure
Good Clinical Practice
Certification
Colleagues
Thomas Loe
Executive Cardiovascular Sales Representative II at Novartis, Owner at Isotope Shielding Technologies, LLC
Kelly Gribowski
Area Business Leader
Bianca Pop
Owner
Alexander Iliyashov
Finance Professional | Master Digital Transformation | Business Analyst | Data Scientist | Data & Machine Learning Engineer | Cloud Architect | Project Manager | Quick Start Engineer | Job
Žiga Kopinšek
global artwork process owner innovative medicines & safety label change & project orbit artwork lead
Other Named Rani Maloney
Frequently asked questions
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Rani Maloney works for Novartis
Rani Maloney's role in Novartis is Documentation And Business Analyst | Consultant
Rani Maloney works in the industry of Pharmaceutical Manufacturing
Rani Maloney's colleagues are Thomas Loe,Kelly Gribowski,Bianca Pop
Rani Maloney's latest job experience is Documentation And Business Analyst | Consultant at Novartis
Rani Maloney's latest education in Rutgers University
