Regulated Industries Consultant

Há 1 mês

São Paulo, São Paulo, Brasil BeiGene Tempo inteiro
Life Science Consultant, Computerized System Validation

We are seeking a highly skilled Life Science Consultant, Computerized System Validation to join our team. As a key member of our global Life Science network, you will be responsible for planning, implementing, and maintaining computerized system validation for our client's SAP S/4 HANA implementation.

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.
  • 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.
Requirements:
  • 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.
What We Offer:
  • 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.

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