
Mahesh Chezhian
Consultant - IT QA & Computer System Validation and Quality Compliance with 5 years of experience in GxP... | Chennai, Chennai, India
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Mahesh Chezhian’s Emails ma****@as****.com
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Mahesh Chezhian’s Location Chennai, Chennai, India
Mahesh Chezhian’s Expertise Consultant - IT QA & Computer System Validation and Quality Compliance with 5 years of experience in GxP Consultation, Regulatory Compliance Assessment, E2E Validation, Gap Analysis, Process Periodic reviews, Project Management, SOx Controls, Internal audits, Change Management, Incident and Problem Management. Acquired strong knowledge on CSV concepts, FDA regulations like 21 CFR Part 11, EU Annex 11, 21 CFR Part 820 and guidance such as GAMP 5, GLP and GMP. IT QM for assigned projects responsibilities include but not limited to vendor evaluation, creation of Project Validation Plan based on the criticality of the proposed system, in consensus with the vendor using SAP for various regions like Asia, Europe and France. Experience in regulatory requirements and documentation as Risk Impact Determination, Validation Plan, Test approach, Test Plan, Test report (System, Integration and UAT), Requirement Traceability Matrix (RTM), Validation report, Cutover report etc. Experienced in the tools such as SAP SolMan for Change Management, Trackwise for QMS, SharePoint managing the Project level documents and Test reports & ServiceNow for maintaining CMDB system profile. Perform process control philosophy and stability reviews coupled with execution of control logic update for various control systems like Emerson DeltaV, ABB 800 XA, Siemens PCS and AB. Execution of control system life cycle management programs which include control system inventory, obsolescence plans, managing spare parts and upgrade/replacement planning as per the standards ISA-18/IEC 62682, ISA-5, ISA-88/IEC 61512, ISA-95 and ISA-84.
Mahesh Chezhian’s Current Industry Astrazeneca
Mahesh
Chezhian’s Prior Industry
Astrazeneca
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Asian Paints
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Biocon
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Work Experience

Astrazeneca
Consultant- Compliance & It Quality Associate
Sat Apr 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Astrazeneca
Associate Consultant- Compliance & It Quality Associate
Tue Jun 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Apr 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
Biocon
Executive Engineer
Wed May 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Jun 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time)
Asian Paints
Trainee Engineer
Thu Feb 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Jan 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time)
Astrazeneca
Consultant
— Present