• Us Citizen

• Green Card

• EAD (OPT/CPT/GC/H4)

• H1B Work Permit

• Corp-Corp

• Consulting/Contract

• UG :- - Not Required

• PG :- - Not Required

• No of position :- ( 1 )

• Post :- 5th Oct 2021

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

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