Quality Control Senior Project
Resume:
Siva Prasad.C.S
Place of Birth Kerala, India
Nationality Indian
Marital Status Un-Married
Mobile number +91-894*******
E-mail Address **********@*****.***
Experienced Laboratory Information Management System (LIMS) Functional consultant with 6+ years of experience in the Quality control and IT industry. Skilled in Labware LIMS Administration and implementation, Strong understanding of Quality processes and GXP best practices. Proven ability to increase efficiency and ensure compliance through the Improving design and maintenance of LIMS System.
Labware LIMS solution designing and consulting.
Process optimization and improvement.
Team management.
Strong communication and training skills.
Experience with regulatory compliance in the pharmaceutical industry.
Industry Focus: Life Sciences, Quality Control, Learning & Development.
APR 2021 Bachelor of Commerce, Tagore University, MP, India.
March 2024 – present Cognizant Technology Solutions, Hyderabad
Senior Project Associate – Static data management and Configuration designing Using LABWARE LIMS.
Design and update solutions for simplification, automation and maintain static data.
Validate functionalities with electronic validation tools.
JUN 2019 – FEB 2024 Dr. Reddy's Laboratories, Hyderabad
Business Consultant – LABWARE LIMS and Automation
Proactively identifying the issues impacting lab compliance developing a plan and its implementation.
Enabled Interfaces with SAP, MES
Management of Change Requests and Quantitative risk assessment.
Creation of Project plans and Development of Test Plan and Test Cases documents.
Resolving GAPs and Process Interlocks by Automation for TAT reduction.
QC Scheduler implementation for QC planning resource allocations and optimization.
Automation using RPA (Auto transfer of results from Empower, Peak integration.
Well versed with functionalities, commonly used concepts, practices, different implementation stages & procedures used across LIMS domain.
Knowledge of laboratory information management systems and how they can be used to improve lab operations and business performance.
Strong project management skills, including the ability to manage timelines, budgets, and resources.
Software Development Lifecycle (SDLC) right from requirement analysis, documentation, (functional specifications, technical design).
Compliance with quality standards and FAT/SAT/IQ/OQ/PQ Documentation.
Well versed with ITIL process mainly Incident Management, Problem Management and Change Management.
Understanding of Industry Standards like GAMP5, FDA’s Electronic Records and Electronic Signatures (ERES) rules, good Knowledge of 21 CFR part 11 Standards.
Good knowledge in all phases of project life cycle from Business Requirement, System Design, Customizing LIMS as per client requirement, Testing and Implementation.
Identifying risks in a timely manner; developing /implementing appropriate mitigation and contingency
Expertise in LIMS Integration with CDS, Standalone Instruments, IOT.
Labware LIMS application development, Migration, Upgrade, validation, Installation of Modules, infra set up for Labware installation.
Debugging all pieces of the system and identify root cause of issues.
Lead the Global LIMS implementation processes to align with the GXP, regulatory and organization s requirements for Application development and support.
Validation of the LIMS Tables, Master data creation and management.
Demonstrate the impact of changes on all functionality in the system. Preparing Functional, Technical documents, Test Scripts, IQ, OQ, PQ Documents for the deployment.
Skilled in business process mapping, requirement study, defining the various specifications for process implementation, and client interaction for resolving issues.
Working knowledge of Agile Scrum.
Scrum team members actively participate in Story Creation, Backlog and Sprint Refinement and Scrum Events (Sprint Planning, Daily Standup, Retrospective, and Reviews).
Support the Scrum Master to identify potential issues and to ensure the team is working as efficiently as possible.
Collaborate with the Product Owner and Scrum Master in Release Planning.
knowledge in ATLASSIAN Jira.
Experience in Application Lifecycle Management
Programming Libraries - LIMS BASIC, SQL, Python,XML
Applications - LABWARE LIMS-Pharma template V5, Crystal reports, Tableau, SSMS(MCSE)
English Malayalam Hindi Tamil Telugu
Hyderabad,15-07-2025
Siva Prasad C S
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