Job Seekers, Please send resumes to resumes@hireitpeople.com

Must Have Skills:

• Shall have min 10 + years of experience in leading global Laboratory Informatics initiatives on Empower Nugenesis implementation upgrade integrations
• 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
• Should be able to understand test methods & its calculation

Detailed 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

Does this position require Visa independent candidates only? No