Life Science Consultant, Computerized System Validation

BeiGene; São Paulo; Presencial; BRL 120.000 - 160.000; Tempo integral

Resumo da oferta

A global life science consulting firm in São Paulo is seeking a Life Science Consultant with strong expertise in SAP validation and GxP regulations. The role involves managing the GxP change control process for SAP S / 4 HANA implementation and collaborating with various stakeholders to ensure compliance. Candidates must have at least 3 years of experience in computerized system validation, strong analytical, problem-solving, and project management skills, and fluency in both Portuguese and English. The position offers a competitive remuneration package with great benefits including flexible working hours.

Serviços

Flat hierarchies and responsibility from the beginning

Diversity and inclusion-focused environment

Flexible working hours and home office

Individual professional development and coaching

Unlimited full employment contract

Excellent remuneration package plus a substantial bonus

Qualificações

• 3+ years of experience in computerized system validation, preferably in the pharmaceutical or biotechnology industry.
• Fluency in both Portuguese and English (written and spoken).

Responsabilidades

• Manage the entire GxP change control process for the SAP S / 4 HANA implementation.
• Gather and document user requirements from business stakeholders.
• Collaborate to author validation deliverables.
• Manage validation activities of cross-functional teams.
• Support resolution and documentation of protocol and test.

Conhecimentos

SAP validation

GxP regulations understanding

Analytical skills

Problem-solving skills

Project management skills

Communication skills

Collaboration skills

Leadership skills

Formação académica

Bachelor's or Master’s degree in Computer Science

Ferramentas

Validation tools

Descrição da oferta de emprego

Life Science Consultant, Computerized System Validation

Sao Paulo, Brazil

Overview

KVALITO Consulting Group is a strategic partner and global Life Science network for regulated industries with a focus on quality. Headquartered in Basel, Switzerland, we have subsidiaries in Germany, Czech Republic, Ireland and Malaysia. With our enthusiasm for progressive technologies and our in-depth knowledge of industry best practices and regulations, we drive effective and efficient project delivery to keep our industry‑leading clients ahead of the competition. Our leadership and consultants combine decades of experience in enterprise environments. To cover all essential technical areas in the field of digital and mobile, KVALITO works with reliable Technology Partners worldwide. For more information, please visit us at www.KVALITO.ch.

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. This includes global GxP systems used across various regions.
• 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.

Minimum Qualification and Experience Education

• Bachelor's or Master’s degree in Computer Science, Information Systems, Engineering, or a related field.

Language

• Fluency in both Portuguese and English (written and spoken).

Work experience

• 3+ years of experience in computerized system validation, preferably in the pharmaceutical or biotechnology industry.

Hard Skills Must Have

• 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.

Soft Skills

• Strong written and verbal communication skills.
• Excellent communication and collaboration skills.
• Excellent people management, leadership, and decision‑making skills.
• Ability to facilitate a holistic perspective and understand business needs.
• Motivated to continuously expand her / his knowledge of the life science industry.
• Ability to work independently and manage multiple priorities in a fast‑paced environment.
• Strong communication and problem‑solving skills.
• Ability to work globally to coordinate the work of associates at all levels.
• Considerable organizational awareness (e.g., the interrelationship of departments, business priorities) including experience in working cross‑functionally and in global teams across cultures.

We offer great benefits

• 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.

Contact If you have the necessary background and experience and would like to join a small team responsible for a truly global operation, then please send your application to recruiting(at)kvalito.ch including your

Application Requirements

• CV, cover letter, and supporting documents (i.e., diplomas, certificates, references).
• Availability – earliest start date.
• Salary expectations.
• Location preference.

We are looking forward to your application.

Your KVALITO Team.