Capa Manager Cqa
Current
Jun 2022 - Present
Who is Devi A? Overview
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Devi A is listed as CAPA Manager, CQA at GSK at GSK, based in India, India, India. AeroLeads shows a matched LinkedIn profile for Devi A.
Devi A previously worked as CAPA Manager CQA at Gsk and Manager QA at Navitas Life Sciences. Devi A holds Master’S Degree, Biotechnology from Kongunadu Arts And Science College, Coimbatore.
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GSK
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Profile bio
About Devi A
A Clinical Quality Assurance professional and a GCP Auditor...Skillful in audit conduct, investigation of quality events, clinical trial document reviews and management of Quality System.Well-versed in GCP,Knowledgeable in GVP, GLP and GCLP,A member of Research Quality Association (RQA) and Society of Quality Assurance (SQA)A Six Sigma Green and Yellow Belt Professional.
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8 roles
Devi A work experience
A career timeline built from the work history available for this profile.
Manager Qa
Aug 2019 - Jun 2022
Tmf Lead
Icon Clinical Research India Private Limited
Sep 2018 - Aug 2019
Lead Auditor - Qa (Gcp)
Clintec (India) International Pvt. Ltd.
Conducting GCP audits, Vendor Management, Quality Issue Management, QA Consultancy, Quality System Management, etc.
May 2016 - Sep 2018
Senior Qa Auditor
Quintiles Research (India) Private Limited
Conduct investigator site audits and internal audits, perform different reviews related to clinical trials, manage quality issues by performing investigations and reviews of Corrective Action and Preventive Action (CAPA) plans, review customer audit reports / regulatory inspection reports and their Corrective Action and Preventive Action (CAPA) plans and.
Nov 2014 - Apr 2016
Senior Executive - Qa
- Responsibilities – Conducting audits and reviews related to clinical trials and management of quality system;Clinical
- Audited about 34 clinical trial sites for studies (with insulins, monoclonal antibodies and small molecules) and 5 CROs.
- Phase of experience – Phase 1, 2, 3, Post-marketing surveillance (PMS) and Bioavailability – Bioequivalence (BA-BE).
- Review clinical study documents such as Protocol, Informed Consent Document (ICD), Investigator’s Brochure (IB), Case Report… Show more Responsibilities – Conducting audits and reviews related to clinical trials and.
- Review clinical study documents such as Protocol, Informed Consent Document (ICD), Investigator’s Brochure (IB), Case Report Form (CRF), Product label, Clinical Study Report (CSR), Trial Master File (TMF) etc.Quality.
- Quality Assurance – preparation and review of Standard Operating Procedures (SOPs), conduct training on GCP and SOPs
Aug 2013 - Oct 2014
Executive - Qa
Conducting GCP audits - clinical trial sites and CROsReviewing clinical trial documentsManagement of quality systems - QA, Clinical and Pharmacovigilance
Mar 2010 - Sep 2012
Clinical Research Associate (Cra)
Consortium Clinical Research Pvt. Ltd.
- Responsibilities – Preparing study documents, conducting protocol training, team management and data management.
- Worked on 4 oncology products, an analgesic and a nutritional food supplement. Phase of experience: Phase 1, 3, PMS and BA-BE.
- Worked at All India Institute of Medical Sciences (AIIMS), New Delhi for “Evaluation of Breast Cancer Patients having undergone the treatment methods like Surgery, Chemotherapy, Radiotherapy and Hormonal Therapy”
Feb 2009 - Feb 2010
2 education records
Devi A education
Master’S Degree, Biotechnology
Kongunadu Arts And Science College, Coimbatore
Post Graduate Diploma, Clinical Trial Management And Regulatory Affairs
Consortium Clinical Research Pvt. Ltd.
FAQ
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Quick answers generated from the profile data available on this page.
What company does Devi A work for?
Devi A works for GSK.
What is Devi A's role at GSK?
Devi A is listed as CAPA Manager, CQA at GSK at GSK.
Where is Devi A based?
Devi A is based in India, India, India while working with GSK.
What companies has Devi A worked for?
Devi A has worked for Gsk, Navitas Life Sciences, Icon Clinical Research India Private Limited, Clintec (India) International Pvt. Ltd., and Quintiles Research (India) Private Limited.
How can I contact Devi A?
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What schools did Devi A attend?
Devi A holds Master’S Degree, Biotechnology from Kongunadu Arts And Science College, Coimbatore.
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