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Life Science Consultant, Computerized System Validation Specialist
2 meses atrás
We are seeking a highly skilled Life Science Consultant, Computerized System Validation Specialist to join our team at BeiGene. As a key member of our global Life Science network, you will be responsible for planning, implementing, and maintaining computerized system validation for our SAP S/4 HANA implementation.
Key Responsibilities- Manage the entire GxP change control process from initiation to closure for the SAP S/4 HANA implementation, ensuring it meets the requirements of project stakeholders.
- Work closely with IT enterprise applications teams, business process owners, and key users to gather and document user requirements from business stakeholders to establish the intended use of the SAP S/4 HANA system.
- Collaborate with project stakeholders to author validation deliverables (e.g., IQ, Validation Plan, Test Plan, Test Scripts, etc.) and revise accordingly based on guidance and feedback from the Quality team.
- Manage validation activities of cross-functional teams to ensure the validation effort is executed to plan and properly documented in the appropriate validation documents.
- Support resolution and documentation of protocol and test.
- Ensure the SAP S/4 HANA system remains in compliance with applicable regulations and internal procedures as changes to the system are made.
- Help maintain post go-live activities such as managing user onboarding documentation, revision release notes assessment for validation impact, assisting with quarterly system access review documentation, etc., in both languages.
- Maintain computerized system validation documentation for the SAP S/4 HANA implementation.
- Bachelor's or Master's degree in Computer Science, Information Systems, Engineering, or a related field.
- Fluency in both Portuguese and English (written and spoken).
- 3+ years of experience in computerized system validation, preferably in the pharmaceutical or biotechnology industry.
- Proven experience in SAP validation.
- Strong understanding of GxP regulations and industry practices.
- Strong analytical, problem-solving, and project management skills.
- Familiarity with validation tools and software testing methodologies.
- Ability to work effectively with cross-functional teams and stakeholders in both languages.
- Flat hierarchies and responsibility from the beginning.
- People-oriented culture.
- Diversity and inclusion-focused environment.
- Global client projects in a multinational environment.
- Flexible working hours and home office.
- Involvement in global conferences.
- Individual professional development, training, and coaching.
- Unlimited full employment contract.
- Excellent remuneration package consisting of a competitive salary plus a substantial bonus.
