Arun J
Senior Manager, Digital Quality and Data Integrity, QA at Agios Pharmaceuticals | Greater Boston
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Senior Manager, Digital Quality and Data Integrity, QA at Agios Pharmaceuticals in May 2022 to Present
Manager, Digital Quality and Data Integrity, QA at Agios Pharmaceuticals in November 2019 to April 2022
IT Validation and Compliance at Alnylam Pharmaceuticals in March 2018 to November 2019
Senior Validation Engineer at Mutex Systems in March 2015 to November 2019
Validation Engineer at Tepha, Inc. in July 2017 to March 2018
Validation Test Lead at Biogen in March 2015 to July 2017
Quality Assurance Associate at InvaGen Pharmaceuticals Inc in January 2014 to March 2015
Teaching Assistant at University of Mississippi in May 2013 to December 2013
Validation Tester at ICSS INFORMATICS LIMITED in May 2011 to August 2011
QA/Validation Trainee at Aurobindo Pharma Ltd in June 2010 to August 2010
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Northeastern University, Master's degree, January 2011 to January 2013
Kakatiya University, Warangal, Bachelor's degree, January 2007 to January 2011
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21 CFR Part 11
Computer System Validation
cGxP
Risk Assessment
Corrective and Preventive Action (CAPA)
Change Control
PQ
Test Cases
Defect Tracking
Standard Operating Procedure (SOP)
Pharmacovigilance
Regulatory Affairs
U.S. Food and Drug Administration (FDA)
GMP
Regression Testing
Software Development Life Cycle (SDLC)
ISO 13485
Laboratory Information Management System (LIMS)
GAP Analysis
Design Specifications
21 CFR Part 210
21 CFR Part 211
ISO 13485:2003
ISO 1491:2007
ICH Q9
GAMP 5
Validation Plan
User Requirements Specification.
Functional Requirements Specification.
Requirement Traceability Matrix (RTM)
21 CFR Part 820
21 CFR Part 11 annex 11
GxP
Data Integrity
GAMP
Traceability Matrix
ComplianceWire (LMS)
ClinPharm Data Analyis Platform (CDAP) - Rudraya
Argus Safety System (RxLogix)
Medical Affairs Request System (Mavens)
Serialization (TraceLink)
Veeva Vault (QualityDocs, PromoMats, eQMS, eTMF, Submissions)
Interactive Response Technology System (Suvoda and EndPoint)
Enterprise Resource Planning, ERP (SAP and IQMS)
Multiple Sclerosis Performance Test (MSPT) - (Cleveland Clinic Foundation)
HP ALM (Applications Lifecycle Management) Tool
Work Instructions
Periodic Review
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Discover more about Agios PharmaceuticalsWhat is Arun J email address?
Email Arun J at [email protected]. This email is the most updated Arun J's email found in 2026.
How to contact Arun J?
To contact Arun J send an email to [email protected].
What company does Arun J work for?
Arun J works for Agios Pharmaceuticals
What is Arun J's role at Agios Pharmaceuticals?
Arun J is Senior Manager, Digital Quality and Data Integrity, QA
What is Arun J's Phone Number?
Arun J's phone (**) *** *** 983
What industry does Arun J work in?
Arun J works in the Pharmaceuticals industry.
Arun J Email Addresses
Arun J Phone Numbers
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