NO OPT & CPT VISA'S
Hello,
My name is Jaya and I am a Staffing Specialist at Veda Info Inc. I am reaching out to you on an exciting job opportunity with one of our clients.
Please find the JD below and kindly respond with the below details if interested:
Job Title: Project Manager / Program Manager | LabWare LIMS
Location with Zip code– Canonsburg, Pennsylvania 15317
Contract duration: 3 years
Job Description:
Shall have min 10 years of experience in handling projects as functional consultant in the areas of LabWare LIMS, CDS, SDMS, eLN, system integration
Need to have successfully managed at least four end-to-end LIMS and Empower implementation projects in larger pharma manufacturing environments.
Well conversant with GAMP and validation requirements for laboratory projects of Cat. 4 and 5
Ability to interact and influence site management and SMEs during the project cycle
Shall have basic process knowledge in pharmaceutical lab process in API, Oral Solid Dosage, Injectables and R&D.
Shall be liaison between site team and core team
Interface with global Directors and Managers (IT, QA, and Business) to identify, communicate, and implement harmonized and optimized processes
Work with Quality SMEs, Corporate Quality, site SMEs, process SMEs, R&D, system owner, process owner, Engineering and/or Manufacturing to identify needs for quality tools
Develop and manage appropriate taxonomies to standardize quality and risk in LIMS
Update and implement global standard operating procedures (SOPs) / Work Instruction / any such procedure
Develop training programs and work with appropriate parties to train users
Develop and improve tools to disseminate lessons learned
Identify metrics and tools to quantify and encourage LIMS success
Serve as the corporate SME for said system.
Act as an expert and thought leader on laboratory and/or manufacturing solutions and systems used to support quality-related processes
Develop, prioritize, and maintain a roadmap of quality tools based on strategic and tactical business priorities
Identify potential vendors to implement new tools, and lead work to select vendors in concert
Assist in developing costs and business case
Work with appropriate parties including IT, IP, and Change Management to successfully acquire and implement new tool
Support coordination, development, and delivery of training on Quality systems, tools and SOPs to manufacturing site Quality teams, Supplier QA, suppliers, Manufacturing, and other relevant functions
Manage the roadmap of LabWare LIMS, CDS, SDMS, CDS/SAP/TW/Documentum integration with LIMS and implementing new capabilities
Manage the projects of site migrations from Caliber LIMS to LabWare LIMS for around 15 India Mfg./R&D sites catering to OSD and API manufacturing
Manage the projects of migrating sites in other LIMS solutions like (StarLIMS, Watson and homegrown solutions) to LabWare LIMS
Must Have Skills
a.Shall have min 10 + years of experience in leading global Laboratory Informatics initiatives on Empower Nugenesis implementation upgrade integrations
b.Business requirement analysis, Cloud Migration, Solution architecting, Design and implementation, Data migration, Performance management, System integrationconsolidation, Configuration and customization, Testing and transition, User training, Computer systems validation
c.Should be able to understand test methods & its calculation
Thanks,
Jaya
Technical Recruiter
Vedainfo Inc
Office: 310-929-2578. EXT: 129
Direct: 310-929-2578.
Certified Women Owned Minority Business Enterprise {WMBE}
3868 Carson Street, Suite 204, Torrance, CA 90503 | Offices: USA, India, Australia, UK and New Zealand
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