Ronakkumar Shah ronakkumar.shah@novartis.com & & +1 212-830-2417 | Quality Assurance,- QA Expert,- Quality Officer • Support document management system and electronic training system Write investigations, CAPA and triage. • Management of the manufacturing and import authorization and the GxP certificates as well as the organization of the law, the notarial attestations and the request of apostles • Maintain Document archival room in a manner to ensure documents are securely stored, controlled and accounted for and in accordance with company policies • Track, compile, maintain and report weekly metrics on e.g. BRFs and other as needed to Quality Management • Provide training to other associates • Support audits and collaborate with main stakeholders • Compile, Issue and Check e.g BRFs • Manage the process for all cGMP Quality Assurance e.g. Change control • Provide training in respective area • Provide the weekly and monthly metrics in respective area and take care of respective KPI's • Manage the process of respective cGMP SOPs • Drive the definition and implementation of the respective areas • Represent the respective area in networks Senior Scientist: • Hands on experience of analytical instrumentation like HPLC(Empower), GC, UV-VIS equipment, UPLC, Karl Fischer and other analytical instruments. • Preparing standard and sample solutions, buffers, reagents and calibrating the instruments for analytical and stability testing of various pharmaceutical drugs as per USP, IP or BP. • Knowledge in Analytical method development / validation/transfer and working in accordance with GMP requirements. • Risk based Assessment includes processes and Risk Assessment tools to solve technical issue. • Troubleshooting and problem solving skill. • Writing Investigations for OOS (out of specification) result and if required then for OOT(out of trend) • Enter and review data in LIMS/SAP. • Experience in reporting writing for NOI’s and follow-up with FDA for the same. • 5S and lean lab projects.

Ronakkumar Shah

Quality Assurance,- QA Expert,- Quality Officer • Support document management system and electronic training system Write investigations, CAPA...

Morris Plains, New Jersey, United States

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Ronakkumar Shah’s Emails [email protected]

Ronakkumar Shah’s Phone Numbers 1212830****

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Ronakkumar Shah’s Location Morris Plains, New Jersey, United States

Ronakkumar Shah’s Expertise Quality Assurance,- QA Expert,- Quality Officer • Support document management system and electronic training system Write investigations, CAPA and triage. • Management of the manufacturing and import authorization and the GxP certificates as well as the organization of the law, the notarial attestations and the request of apostles • Maintain Document archival room in a manner to ensure documents are securely stored, controlled and accounted for and in accordance with company policies • Track, compile, maintain and report weekly metrics on e.g. BRFs and other as needed to Quality Management • Provide training to other associates • Support audits and collaborate with main stakeholders • Compile, Issue and Check e.g BRFs • Manage the process for all cGMP Quality Assurance e.g. Change control • Provide training in respective area • Provide the weekly and monthly metrics in respective area and take care of respective KPI's • Manage the process of respective cGMP SOPs • Drive the definition and implementation of the respective areas • Represent the respective area in networks Senior Scientist: • Hands on experience of analytical instrumentation like HPLC(Empower), GC, UV-VIS equipment, UPLC, Karl Fischer and other analytical instruments. • Preparing standard and sample solutions, buffers, reagents and calibrating the instruments for analytical and stability testing of various pharmaceutical drugs as per USP, IP or BP. • Knowledge in Analytical method development / validation/transfer and working in accordance with GMP requirements. • Risk based Assessment includes processes and Risk Assessment tools to solve technical issue. • Troubleshooting and problem solving skill. • Writing Investigations for OOS (out of specification) result and if required then for OOT(out of trend) • Enter and review data in LIMS/SAP. • Experience in reporting writing for NOI’s and follow-up with FDA for the same. • 5S and lean lab projects.

Ronakkumar Shah’s Current Industry Novartis

Ronakkumar Shah’s Prior Industry
Amneal Pharmaceuticals | Sun Pharma | Novartis

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Work Experience

Novartis

QA Specialist/ Operations

Mon Apr 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Present

Novartis

Senior Scientist

Wed Jun 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Mar 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time)

Sun Pharma

Chemist II

Thu Jan 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun May 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time)

Amneal Pharmaceuticals

chemist

Mon Aug 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Dec 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time)

Skills

Languages

FAQ About Ronakkumar Shah

Ronakkumar Shah is located at
Morris Plains, New Jersey, United States

Ronakkumar Shah is a
Quality Assurance,- QA Expert,- Quality Officer • Support document management system and electronic training system Write investigations, CAPA and triage. • Management of the manufacturing and import authorization and the GxP certificates as well as the organization of the law, the notarial attestations and the request of apostles • Maintain Document archival room in a manner to ensure documents are securely stored, controlled and accounted for and in accordance with company policies • Track, compile, maintain and report weekly metrics on e.g. BRFs and other as needed to Quality Management • Provide training to other associates • Support audits and collaborate with main stakeholders • Compile, Issue and Check e.g BRFs • Manage the process for all cGMP Quality Assurance e.g. Change control • Provide training in respective area • Provide the weekly and monthly metrics in respective area and take care of respective KPI's • Manage the process of respective cGMP SOPs • Drive the definition and implementation of the respective areas • Represent the respective area in networks Senior Scientist: • Hands on experience of analytical instrumentation like HPLC(Empower), GC, UV-VIS equipment, UPLC, Karl Fischer and other analytical instruments. • Preparing standard and sample solutions, buffers, reagents and calibrating the instruments for analytical and stability testing of various pharmaceutical drugs as per USP, IP or BP. • Knowledge in Analytical method development / validation/transfer and working in accordance with GMP requirements. • Risk based Assessment includes processes and Risk Assessment tools to solve technical issue. • Troubleshooting and problem solving skill. • Writing Investigations for OOS (out of specification) result and if required then for OOT(out of trend) • Enter and review data in LIMS/SAP. • Experience in reporting writing for NOI’s and follow-up with FDA for the same. • 5S and lean lab projects. Novartis

Ronakkumar Shah currently works in the
Novartis

Ronakkumar Shah specializes in
Quality Assurance,- QA Expert,- Quality Officer • Support document management system and electronic training system Write investigations, CAPA and triage. • Management of the manufacturing and import authorization and the GxP certificates as well as the organization of the law, the notarial attestations and the request of apostles • Maintain Document archival room in a manner to ensure documents are securely stored, controlled and accounted for and in accordance with company policies • Track, compile, maintain and report weekly metrics on e.g. BRFs and other as needed to Quality Management • Provide training to other associates • Support audits and collaborate with main stakeholders • Compile, Issue and Check e.g BRFs • Manage the process for all cGMP Quality Assurance e.g. Change control • Provide training in respective area • Provide the weekly and monthly metrics in respective area and take care of respective KPI's • Manage the process of respective cGMP SOPs • Drive the definition and implementation of the respective areas • Represent the respective area in networks Senior Scientist: • Hands on experience of analytical instrumentation like HPLC(Empower), GC, UV-VIS equipment, UPLC, Karl Fischer and other analytical instruments. • Preparing standard and sample solutions, buffers, reagents and calibrating the instruments for analytical and stability testing of various pharmaceutical drugs as per USP, IP or BP. • Knowledge in Analytical method development / validation/transfer and working in accordance with GMP requirements. • Risk based Assessment includes processes and Risk Assessment tools to solve technical issue. • Troubleshooting and problem solving skill. • Writing Investigations for OOS (out of specification) result and if required then for OOT(out of trend) • Enter and review data in LIMS/SAP. • Experience in reporting writing for NOI’s and follow-up with FDA for the same. • 5S and lean lab projects.