Digital Functional Analyst - Senior - Remote

Location: Remote from India Working hours: CET Time Zone Contract start date: 1st September 2026 Contract duration: 6 months renewable Responsibilities: To translate the roadmap into functionnal features (and documentation) for the developers. has around 5-7+ years of experience in development (backend and frontend)3-5 year of functionnal analystmust have knowledge in GxP (GMP) environment, in Jira and Xray, SQL,must be fluent in englishnice to have : knowledge in data analysis and UX/UI designWe are not looking for a PO or a dev. Sentinel is enterprise-wide platform designed to transform Statistical Process Control (SPC) across the global manufacturing network. It will serve as a unified, multilingual, GxP-compliant solution, consolidating and replacing a fragmented landscape of more than six legacy trending tools including SPC Ignyte, StaCS-CAPVER, Statistica/Apex, QlikView, Excel, and various local tools currently deployed across 34 manufacturing sites worldwide. The objectives of this role are to: Support functional analysis and requirements gathering to define Sentinel capabilities in line with business and operational needs.Enable harmonization and integration of manufacturing data from diverse source systems into the Sentinel platform, ensuring unified SPC monitoring and analysis.Ensure compliance with GxP regulations and provide technical expertise in manufacturing process monitoring and SPC methodologies.Contribute to the GxP documentation of the project, ensuring alignment with regulatory and quality standards.Collaborate with the Product Owner (PO), UX/UI designers, and the development team to deliver tailored solutions for both site-specific and global requirements, ensuring data consistency and regulatory compliance. Targets and expectations of the requested service Technical Contributions UX/UI Partnership Collaborate with UX/UI designers and the Product Owner to define user workflows, shape functional requirements, and continuously optimize platform usability and user experience.GxP Documentation Create, review, and maintain functional requirements, acceptance criteria, and technical documentation in full alignment with GxP compliance standards and internal quality processes.Validation testing Validate technical designs, Sentinel configurations, and dashboards to ensure strict adherence to GxP and applicable regulatory requirements throughout the project lifecycle.Collaboration Document Management Work closely with the Product Owner, Business System Owenr and technical experts to document and refine backlog items, ensuring clarity and actionability for the development team.Discussion Leadership Lead technical discussions, facilitate cross-functional alignment, and provide subject-matter expertise on Sentinel processes, SPC methodologies, and manufacturing data requirements.Project Alignment Ensure consistent alignment across teams on project goals, milestones, timelines, and deliverables, proactively identifying and addressing risks or dependencies. Functional and technical environment The candidate will have to justify its expertise in the following activities, fields, software etc.: Manufacturing Processes & Statistical Process Control (Mandatory): Strong expertise of manufacturing parameter contextualization and process-oriented data analysis,SQL (Mandatory) Solid SQL expertise, including query writing and optimization for data extraction and analysis.GxP Documentation & Validation (Mandatory): Deep expertise of GxP compliance in manufacturing environments, including electronic records management, audit trail requirements, and system validations standards.Proven expertise with pharmaceutical manufacturing validation protocols and regulatory documentation practices.Agile Methodology (Mandatory): Demonstrated expertise working within Agile development teams, including sprint planning, backlog refinement, and stakeholder collaboration specifically in the context of complex manufacturing systems.Expertise in the use of Jira and Xray for test management and traceability within a regulated context.Requirements Analysis (Mandatory): Expertise in gathering and analyzing user requirements from diverse manufacturing roles (operators, engineers, quality managers).Expertise in role-based access design and manufacturing workflow optimization.Expertise in translating manufacturing processes into functional system requirements.Optional expertise: Expertise of SPC methodologies, control chart applications, and manufacturing workflows.Expertise in the use of Snowflake as a cloud data platform.Expertise in statistics calculation.Expertise in Continued Process Verification (CPV), Process Monitoring (PrM), Environmental and Personnel Monitoring (EM/PM), and Analytical Lifecycle Management within regulated pharmaceutical environments. .