· Author Quality Plan and Validation Plan for different applications
used in Medical Device manufacture.
· Perform Criticality Assessment following the Good
Manufacturing Practices for different applications used in Medical Device
manufacture and analyze their impact on Patient Health, Product Quality and
· Perform Risk Analysis for different applications
used in Medical Device manufacture that includes identifying the Potential Hazards and Mi... read more
and deploying dynamically scalable, available, fault-tolerant, and reliable
applications on the Cloud
complex, multi-tier applications on Cloud Platforms
and deploying enterprise-wide scalable operations on Cloud Platforms
design and buildout of the new cloud infrastructure and services in AWS
environment using industry best practices
with application teams to design, develop and deliver cloud native solutions
and services, and power the digital transformations across business ... read more
· Work as part of the technical team and involved in the design, development of ETL packages, data warehouse architecture, reporting and
· Work on ETL packages with different data sources
(SQL Server tables, Flat Files, Excel source files, etc.) and the load the data into destination tables, Flat Files,
Excel files etc., by performing different kinds of transformations using SSIS
· Design different kind of Reports (pie charts,
graphs, bar, maps, etc.,) on SQL SSRS as per the client requirement.
... read more
• Deliver detailed architecture for Bigdata Platform
Migration to HADOOP.
• Identify components, services migration to Hadoop Tools to
be utilized in HADOOP.
• Connectivity and outlay dependencies between existing
platform and new platform Logical flow diagram Design upstream and downstream
flow Automate Alerts, Monitoring, and Server job processes, ensures standards
and best practices are established and met for consistent and accurate use of
Hadoop across the company.
• Standards and Best practices of utilizing Tableau b... read more
• Configuring and validating computer systems for
small scale biologics manufacturing and Lab equipment.
• Writing and executing URS and Validation
protocols IQO, QPQ.
• Ensuring part 11 compliance.
• Working with vendors to solve problems, write
and execute validation protocol s for related software
• Develop User Requirements Specification (URS) the document by collaborating with the BPO's, Project Managers to gather the user
• Develop Functional Requirement... read more
Responsibilities:• Review documents including clinical study reports, labeling
drafts and validation and stability protocols and reports.
• Execute process, utility, equipment validation and verification protocol
• Generate and review standards of CSV deliverables, document those
deliverables in compliance with 21CFR Part11.
• Author specific requirement documents and validation test script.
• Develop and Execute Installation, Operational, and Performance Qualification
(IQ, OQ and PQ) protocols, and prepare a Final Validation Report.... read more
· Understand and support any ERP
process and how it may be best utilized by the business, including “hands-on”
support as needed
· Create intuitive reports, dashboards
and other Business Intelligence products using tools such as Crystal Reports
and the IQMS dashboard tool
· Assist the IT Manager with
evaluation of proposed additional BI tools
· Work with management, engineering,
production, finance, and other members of IT to bring about continuous process
improvement as it relates to utilization of ... read more
Experienced in S4 HANA Embedded
TM or TM 9.5/9.4
Experienced in multiple Go
Lives with 6 to 8 years of TM functional experience
Experienced in configuring
several modes of transports in TM (Ocean, Air, Rail, Parcel, FTL, LTL, Intermodal)
Expert in Transportation
Planning, Carrier Selection, Tendering
Expert in Transportation Charge
Management & Freight Costing
Experienced in TM – EWM
Integration and TM – EHS Integration
Experienced in interface
map... read more
· Able to transformation planning, from source Multiple ECC systems one S/4HANA System
· Deeply skilled in SAP Financial Accounting, Controlling, and integration to SD, HCM, Success Factors
· Deeply skilled in AR/Credit/AP, Purchasing
· Has implemented 1 S/4HANA project
· Guide the client through and deliver a transformation roadmap
· Clear knowledge of Central Finance use cases, guiding the client from many ECC systems with consolidation to one S/4HANA Finance system
·&... read more
Job Responsibilities:· Ensure compliance with internal and external GxP system policies and regulations.
· Implement or schedule validation testing and studying clinical product characteristics or requirements and conferring with management to determine validation objectives and standards.
· Perform validation of GxP and non-GxP systems and collaborate with teams in making critical decisions with respect to validation.
· Perform risk assessments in determining GxP applicability associated risk and resulting validation activities ... read more