Business Analyst

Overview:

Job title: Business Analyst

Location: Woodside/ REMOTE

Requirements:

Responsibilities: • Validation Strategy: Develop and implement a validation strategy for Spark Integration including QMS Replacement (Veeva Spark to Veeva Roche), ensuring alignment with regulatory requirements, industry best practices, and Roche internal standards.

• Validation Plans and Protocols: Create validation plans and protocols for digital solutions, including data pipelines and interfaces, automation applications, data-driven models, and statistical tools. Ensure that all validation activities are properly documented and executed according to established procedures.

• Risk Assessment: Conduct risk assessments to identify potential risks associated with the use of digital solutions in a GMP environment. Develop risk mitigation strategies and ensure that appropriate controls are in place.

• Testing and Qualification: Ensure that the testing activities are aligned with the Roche standards, that the testers perform testing and qualification activities for digital solutions, particularly with QA SMEs. This includes executing test cases, analyzing results, and documenting findings.

• Compliance and Documentation: Ensure that all validation activities are compliant with relevant regulatory requirements, such as GMP and data integrity guidelines. Maintain accurate and up-to-date validation documentation, including validation plans, protocols, reports, and change control documentation.

• Collaborate with IT Business Partners, Stakeholders, Product Owner and Development Team - Tester, Developer, IT Architects, Adoption Services, external Vendors.

• Strives for harmonisation of business processes across sites and departments by propagating common standardised data models, applications and technologies that are in line with the cross-

functional or Informatics strategies and architectures.

• Explore opportunities and initiatives to grow professionally, in a self-assignment way and take additional roles as squad leads as appropriate.

• Displays skills and capabilities in the area of business partnering and/or product management.

• Demonstrate ability to perform detail-oriented work with a high degree of accuracy and able to explain complex concepts with clarity and simplicity.

• Demonstrate knowledge of current GxP requirements and documentation standards, with the ability to write validation docs

• Managing communications with multiple business units as well as internal IT cross-functional teams.

• Ensures delivery in line with Spark Integration Project

Candidate requirements:

• Understanding of software development lifecycle models and experience with business/end-user applications.

• Strong knowledge in validation principles and practices in a GMP environment. Experience in validating digital solutions, including Release Management processes and controls, as well as validation of. Familiar with test automation process and development.

• Experience with business/end-user application - prior experience with patient access or physician portals a plus.

• Project-based work experience in the pharmaceutical industry

• Experience with implementing Technical Operations System and Equipment

• Familiar with Manufacturing, Quality, intercompany order processing, and outbound logistics processes.

• Constantly looking for improvements in ways of working (Process/tools/organisation) and works independently.

• Ability to understand technical processes, with strong communication skills and the ability to train/coach others

• Good communication skills - fluent in written and spoken english. .

• Language - English / Travel Requirement - 10% (as needed)