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Arpita Patel

Sr. Manager, Quality Assurance

Sr. Manager, Quality Assurance at Kiniksa

Waltham, Massachusetts

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Arpita Patel's Email Addresses & Phone Numbers

Arpita Patel's Work Experience

Kiniksa Pharmaceuticals

Sr. Manager, Quality Assurance

Lexington, Massachusetts

Biogen

Senior QA- QA operation and compliance

August 2015 to January 2017

Genzyme

Compliance Specialist

June 2011 to March 2014

Framingham

Arpita Patel's Education

Sardar Patel University

Bachelor, Pharmacy

New Jersey Institute of Technology

Master of Science, Pharmaceutical Engineering

Arpita Patel's Professional Skills Radar Chart

Based on our findings, Arpita Patel is ...

Self-sufficient
Critical
Loner

What's on Arpita Patel's mind?

Based on our findings, Arpita Patel is ...

52% Left Brained
48% Right Brained

Arpita Patel's Estimated Salary Range

About Arpita Patel's Current Company

Kiniksa Pharmaceuticals

Frequently Asked Questions about Arpita Patel

What company does Arpita Patel work for?

Arpita Patel works for Kiniksa Pharmaceuticals


What is Arpita Patel's role at Kiniksa Pharmaceuticals?

Arpita Patel is Sr. Manager, Quality Assurance


What is Arpita Patel's personal email address?

Arpita Patel's personal email address is a****[email protected]


What is Arpita Patel's business email address?

Arpita Patel's business email addresses are not available


What is Arpita Patel's Phone Number?

Arpita Patel's phone (413) ***-*438


What industry does Arpita Patel work in?

Arpita Patel works in the Biotechnology industry.


About Arpita Patel

📖 Summary

Sr. Manager, Quality Assurance @ Kiniksa Pharmaceuticals Lexington, MassachusettsSenior QA- QA operation and compliance @ Biogen • Review GMP master batch record and solution record for compliance related issue• Perform disposition of drug substance• Perform Investigation/Deviation and event closure (Ishikawa diagram, 5 Why’s, 7Ms, timeline tool, concentration chart, DMAIC)• Identify gaps in existing quality systems and proposes solutions to senior leadership team• Prepares and analyzes KPI metrics for quality compliance • Mentors and trains less experienced associates across QA functions • Site trainer for initiation, investigation , review/approval of deviation and CAPA• Author monthly deviation trend report for Cambridge site • Review and approve quarterly pest control trend report• Review and approve production alarms and approve monthly technical report• Participate as a scribe and strategist in external agencies audit (EMEA, FDA, MFDS, Turkish agency,ANVISA)• Active training coordinator for quality organization and developed an onboarding training plan for easy transition of new employees to utilize maximum resource• Detail understanding of all manufacturing process including cell culture, media and buffer preparation and protein purification From August 2015 to January 2017 (1 year 6 months) Compliance Specialist @ Genzyme • Review and approve Batch production records, QC analytical data and associated logs for intermediate and Final release of product• Manage the batch review process in conjunction with manufacturing organization to ensure compliance and timely release• Provide Quality support and guidance to Manufacturing and Support operations to ensure a continuous culture of compliance to cGMP• Participate in inspections at the site by Regulatory Agency and support QA Operation during Internal Quality audits • Write/revise/review and approve SOPs • Review and release Action Notices, Work Orders and Cleaning Verification.• Designed Training maps, workshop and On The Job training for new employees• Delivered training to the new employees to perform QA job function to establish maximum support to manufacturing • Review and approve QA minor and major deviation for QA operation and CAPA• Assess Product lot impact, Root Cause and CAPAs for major and critical deviation• Made critical decision to ensure compliance of manufacturing and timely release of bulk product • Extensive experience on working with third party to resolve issue and ensure timely release of bulk product (Quantic)• Detail understanding of all manufacturing process including cell culture, media and buffer preparation and protein purification From June 2011 to March 2014 (2 years 10 months) FraminghamQuality Coordinator @ Genzyme • Reviewed all site and product specific MS,MF and PRs to compile Part number of raw materials and Vendor information• Participate in the preparation of audits/inspection • Generated Approved Vendor list (AVL) for Framingham site From April 2011 to June 2011 (3 months) FraminghamQA Associate @ Immunomedics • Review and approve batch production documentation generated at CMO for manufacturing, packaging and labeling of clinical products• Participate in the Audit at the Contract Manufacture Organization (CMO)• Review analytical test results and release raw materials for manufacturing• Generate CofA and CofC for disposition of clinical drug substance and drug product• Participate in investigations, corrective action/preventive action (CAPA), standard operating procedure (SOP) preparation/revision/review From February 2011 to April 2011 (3 months) morris town, NJManager, Product quality @ Momenta Pharmaceuticals From January 2017 to January 2019 (2 years 1 month) Quality Engineer @ Genzyme • Investigate Environmental Monitoring and Critical Utility excursions, and Perform root cause analysis (Fish bone) to identify definitive root cause • Determine and implement CAPA for the recurring deviations to prevent their reoccurrence. • Author quarterly EM/CU trend reports• Participate in investigation teams during the analysis of unplanned events or discrepancies and provide recommendations to fulfill corrective and preventive actions (CAPAs) and compliance improvements• Participate in Root Cause Analysis meetings for critical deviations including contamination in manufacturing facility• Review and release Action Notices• Facilitate weekly Environmental Action Committee meeting with cross-functional team• Represent Contamination Control team on Facility shared services and Engineering Projects• Review and approve for HEPA certification• Write/revise/review and approve SOPs • Working on Change control and participate in Risk Assessments for trend and major deviations From March 2014 to August 2015 (1 year 6 months) Manufacturing Associate @ Lonza • Perform aseptic procedures in biosafety cabinets and submit samples in LIMs• Perform CIP and SIP of the media/ Harvest tanks and product transfer skid• Review documentations daily, ensuring all documentation is clear, concise and accurate for easy reference• Use various lab equipment, pH meter, conductivity meter, osmometer, scales and pipette• Maintains records and clean room environment to comply with regulatory requirements• Lead daily manufacturing operations in a GMP environment on the floor, responsible for co-coordinating with member of facilities, engineering , validation, QA, QC on a regular basis to ensure timely completion of daily activities From November 2010 to February 2011 (4 months)


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In a nutshell

Arpita Patel's Personality Type

Introversion (I), Sensing (S), Thinking (T), Perceiving (P)

Average Tenure

1 year(s), 3 month(s)

Arpita Patel's Willingness to Change Jobs

Unlikely

Likely

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