Liaison between business and IT. Develop functiona specififcations from user requirements and interraction with business users and technical consultants from LabWare. Interact with the business users in reviews and elicitation of details function specs. Experience: 6 to 9 years.
Expected to be dedicated 100% to the program
Working in collaboration with the ITS Functional Expert Leader and / or ITS Project Leader and other internal and external Business Analysts and Developers, write Functional Specifications for the Sanofi LabWare LIMS core model solution (BioLIMS)
Work with Business Analysts and Users as appropriate to gather information necessary to build detailed IQ, OQ / SIT and PQ / UAT Test Scripts, Test Prerequisites and Test Data Sets within ALM and LIMS
Ensure assigned deliverables are submitted to meet required level of quality with minimal defects
Participate and support informal and formal test execution by other ITS and Business team members
Test defect / anomaly tracking and follow-up
Provide to Stream Lead and / or Project Coordinator weekly updates on progress including accurate Estimates to Complete any ongoing tasks
Participate and actively contribute to assigned project meetings
Other tasks and duties as assigned by Sanofi
Key Attributes Required of Candidates for this Role:
Strong drive to accomplish assigned tasks, a "self starter”
Experience with global projects in regulated GMP lab environments to implement industry standard tools for one or more of the following: LIMS, LES, CDS
Collaboration with internal LIMS team, external LabWare Developers and internal Business users to develop a new LIMS solution for Sanofi.
Prior experience writing functional requirements for LIMS implementations in GMP-regulated environment (LabWare LIMS preferred).
Experience in role of a Functional Application Expert / BSA for LIMS project (LabWare LIMS / LabWare ELN preferred).
Experience developing IQ, OQ / SIT and PQ / UAT scripts and data sets for LIMS.
Deep knowledge and experience applying GXP regulations and Computer Validation principals in support of LIMS validation project
Understanding of industry standard tools and processes for one or more of the following: QMS, Web Applications, LIMS, ELN, LES, ERP, etc.
Perform and/or coordinate the implementation of the functional or technical parameterization
Design test cases covering complex system functionality
Design, write and execute system integration test scripts
Ensure ITS integration
Contribute to solutions qualification
Create and maintain deployment kits for solutions under his/her responsibility
Contribute to or co-lead completion of specific programs and projects
Lead or co-lead ITS functional risk assessment and management for her/his functional area
Independently or collaboratively determine and develop approaches to solutions
May represent the organization in providing solutions to difficult technical issues
Evaluate users' business requirements, present capabilities and recommend solutions
Understanding of Good Document Management principals
Demonstrated technical writing and oral communication skills
Able to work within a team using established methodologies and procedures
Experience managing requirements / specifications, test cases and risks with Client Application Lifecycle Management preferred.
Flexibility to adopt, embrace and work on project under Sanofi PUMA and other related internal processes and procedures, principles and program methodology
Must be a good team player, be motivated to meet commitments, be accountable to achieve goals and targets while maintaining professional relationships
Strong collaborator across all teams and streams in the completion of assigned tasks and those of other team members
Take ownership of assigned tasks and be accountable for their completion as per defined project schedule
Be transparent and thoughtful in communication
Respect needs of various team members and stakeholders
Maintain open and honest relationships with others on ITS and Business teams
Escalate and identify potential issues to IPL and others on the team in a timely and responsible manner
Post-secondary education in chemistry, biology, computer science or related field
Associate Degree with 7 years of work experience
Bachelor Degree with 5 years of work experience
Four or more years developing, implementing or supporting electronic systems
Relevant job experience in FDA or GXP regulated pharmaceutical or biotechnology industry
Minimum three years of experience in regulated industry (SOX and/or GXP)
Proven experience with business and technical requirements analysis