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Kharghar
Vipul Ssardal

Vipul Ssardal

Senior CSV QA / Data Integrity

Pharmaceutical / Bio-tech

Kharghar, Raigad

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About Vipul Ssardal:

Result-oriented Professional with13 Years diversified experience in QA(CSV) , Data Integrity , Control Systems ; targeting senior level assignments with an organization of repute.

Experience

•Rich experience in leading cross functional teams to develop/validate/maintain computerized systems, address existing gaps. Provide Leadership to maintain a business wide culture of quality & work collaboratively to set quality strategic direction. 

• Implementing Change control& Deviation controls for computerized systems. 

• Establishing, implementing, & improving QA infrastructure& procedures, process, & quality standards in accordance with global standards. 

• Proven Track Record in conducting data mapping activities (DIRA) across the production systems to identify & mitigate the risk to data. Securing the data within the Data Lifecycle.

• Contributed in the development/trainingof Data Integrity policies in line with Industry guidance (FDA, EU, MHRA, ISPE & so on). 

• Supervised overall maintenance activities of the Computerized Systems – Periodic user access reviews, Periodic audittrail reviews, Periodic Data backup / Restore, Data Archiving, Disaster Recovery, Periodic Incident review, Re-evaluation projects. 

• Communicated findings in a clear, structured manner; developing cordial relations with stakeholders. 

• Evaluated, tested & implemented software updates on production systems in a controlled manner. 

• Mapped client requirements, analyzing workflows, upgrading paper system to electronic systems. 

• Acted as a Facilitator between organization & team; worked with the Engineering Managers & other Pool Owners to meet team needs & requirement & ensured that team progresses on assigned task. 

• Expertise in Engineering & validation of Distributed control systems / ESD systems in diverse domain such asPetrochemical, Paper, Pulp, Power, Off-shore Platforms & oil Industries. Preparation of Functional Design Specification, Implementation & testing of logic, sequences, control loops as per the designed document, FAT.

• Executed Commissioning activities comprising Inspection of as ship drawings & BOM, Checking the Health & safety norms at site, Supervision of erection of panels & laying of cables, Power-up of the system, Loop checking & loop tuning, Accomplishment of SAT, conducting onsite training sessions on DCS, PLC, & SCADA, Test runs support for the plant. 

• Supervised Servicing & Sales support initiatives including Software Upgrades, Preventative Maintenance for DCS, Hardware upgrades. Provided emergency supportto customers for resolving their technical issues. 

• Actively participated indiversity & Inclusion team for Alcon Batam Site.

Education

BE Instrumentation from Mumbai University

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