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Solution analyst – STEP - LIMS
Actively Reviewing
Sandoz India
Job Description
Major Accountabilities
Minimum Requirements:
- Lead workshops and interviews with end users, lab leadership, QA/regulatory and operations to capture functional and non-functional requirements for new LabVantage site deployments.
- Produce clear, comprehensive User Requirements Specifications (URS) and scope documents tailored to site needs, compliant with company/regulatory standards (e.g., GxP) and in line with global LIMS template.
- Translate business needs into traceable, testable requirements; manage requirements versioning and change control.
- Collaborate with external IT service providers, solution architects, developers, integrators, and validation engineers to ensure requirements are implementable and design decisions are documented.
- Facilitate design review sessions and walk-throughs with business stakeholders to validate proposed solutions.
- Ensure technical integration with SAP, other non-SAP systems and lab instruments.
- Support development of functional specifications, use cases, process maps, data mappings, and configuration matrices as needed.
- Coordinate and support User Acceptance Testing (UAT): develop UAT scripts from URS, triage issues, and track resolutions.
- Provide guidance and support to end‑users including training materials or hands‑on sessions when needed.
- Work with validation/QA to develop validation plans and ensure requirements coverage in test protocols.
- Manage stakeholder expectations, communicate project status, risks, and impacts, and escalate issues as needed.
- Maintain traceability matrices and ensure requirements link through design, test, and deployment artifacts.
- Contribute to deployment planning, cutover activities, and post-go-live support/lessons learned.
- Requirements Analysis: Measure the effectiveness of collaborating with business stakeholders to gather and analyze requirements, ensuring they are clearly defined and documented.
- Solution Design: Track the development of comprehensive solution designs that align with business objectives and leverage different technologies.
- Implementation Management: Measure the quality, timeliness, and budget adherence of implemented technology solutions.
- Integration: Evaluate the seamless integration of systems and the resolution of any technical challenges that arise.
- Stakeholder Engagement: Measure the effectiveness of acting as a liaison between technical teams and business stakeholders, facilitating effective communication and collaboration.
- Testing and Quality Assurance: Track the development and execution of test plans to ensure solutions meet business requirements and quality standards.
- Documentation: Measure the completeness and accuracy of documentation for solution designs, implementation plans, and testing results.
- Training and Support: Evaluate the effectiveness of training and support provided to end-users.
- Regulatory Compliance: Ensure that all solutions comply with relevant regulatory requirements and industry standards.
Minimum Requirements:
- Bachelor’s degree in Computer Science, Information Technology, Industrial Engineering, Biomedical Engineer, Business Administration, or related field; (Master’s degree is preferred)
- Certification in project management methods (Agile, ITIL, Prince 2, PMI) is a plus.
- Experience with Agile/DevOps methodologies; Certification is a plus
- 5+ years of experience in project delivery and/or application management or IT services within a multinational organization.
- Expert knowledge and experience in key Laboratory products (e.g. LabVantage LIMS; Scitara, Other LIMS) and in the implementation and operations of those.
- GxP and CSV proven methodology knowledge
- Experience as a LIMS Deployment lead in Pharma Industry in several manufacturing sites (roll-outs).
- LIMS Integration with other systems experience in Pharma Industry (SAP, Veeva, etc)
- Good leadership, communication, and collaboration skills.
- Effective communication and stakeholder management skills, with the ability to explain complex technical concepts to non-technical audiences.
- Strong analytical and problem-solving skills.
- Strong leadership and team-building skills
- Proven ability to work effectively in a fast-paced, dynamic environment and drive change and innovation.
- Experience in managing global projects and working in diverse cultural environments.
- Proficiency in using advanced software tools and platforms relevant to the job.
- Experience with ITIL frameworks and other service management methodologies.
- Analytical Thinking.
- Business Acumen.
- Change Management.
- Influencing.
- IT Governance.
- Organization Development.
- Planning.
- Presentation Skills.
- Servant Leadership.
- Stakeholder Management.
- English.
Required Skills
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