Descrizione dell'offerta
Summary
We are seeking a detail-oriented and analytical Serialization Business Analyst to join our team. In this role, you will act as a bridge between technical teams, business stakeholders, and external partners to ensure the successful implementation and optimization of serialization systems. You will play a critical role in driving compliance with global regulatory requirements, enhancing supply chain visibility, and supporting end-to-end product traceability.
Essential Duties and Responsibilities
- Business Analysis & Requirements Gathering: Collaborate with stakeholders to understand business needs, identify gaps, and translate requirements into functional specifications.
- Analyse serialization regulations (e.g EU FMD) and align system capabilities with compliance requirements.
- Map and document end-to-end business processes, focusing on serialization and traceability workflows.
- Project Coordination & Stakeholder Management: Work closely with project managers, developers, QA teams, and external solution providers to support serialization system implementations and upgrades.
- Act as a liaison between business units and IT, ensuring smooth communication and alignment on deliverables.
- System & Data Management: Assist in the configuration, testing, and validation of serialization systems (e.g, TraceLink, rfxcel, Track and Trace, IRIS).
- Support the design and management of master data, serial number generation, and aggregation processes.
- Troubleshoot serialization issues, coordinate resolution efforts, and recommend process improvements.
- Documentation & Compliance: Maintain detailed documentation, including business requirement documents (BRDs), functional specs, test scripts, and training materials.
- Ensure systems and processes align with industry best practices and meet GxP and regulatory compliance standards.
- Other duties may be assigned.
Qualifications
- Functional and technical knowledge in the area of Serialisation.
- Team management for internal/external resources based in different regions.
- Ability to communicate and collaborate with other IT professionals and business stakeholders.
- Proven analytical and problem resolution skills.
- Proactive responsible individual, able to set own action plans.
- Communicate status, solutions, and concerns.
- Establish and maintain strong relationships within the business/IT leadership.
- Strong oral and written communication skills.
- Process oriented and committed to superior quality.
- Ability to travel within and outside of the EMEA region.
- Ability to search for innovative solutions and find ways to overcome obstacles.
- Ability to develop functional specifications.
- Positive and Quick Learning attitude.
- Ownership and Leadership driving to completion.
- Team Player and support constructive debate.
- Understand and follow appropriate SDLC & quality validation processes.
Education and Experience
- Bachelor’s degree in related field required.
- 5 – 10+ years of Serialisation experience.
- Experience working with technology vendors.
- Experience in project management.
- Expertise in healthcare and connected technology solutions.
- Experience in Serialization for pharmaceutical environment.
- Knowledge of IT governance and operations.