Life Science Consultant, Computerized System Validation

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Life Science Consultant, Computerized System Validation [Sao Paulo, 04829-300], [Guarulhos, 02141-000], [Campinas, 11608-545], [São Bernardo do Campo, 09700-000], [Santo André, 09000-000], [São José dos Campos, 12200-000], [Ribeirão Preto, 14000-000], [Osasco, 06000-000], [Sorocaba, 18000-000], São Paulo - Brazil | Posted - 28/04/23 Overview

We are looking for enthusiasts

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

Life Science Consultant, Computerized System Validation

Location: Sao Paulo, Brazil The Life Science Consultant, Computerized System Validation is responsible for planning, implementing, and maintaining computerized system validation for our client’s SAP S/4 HANA implementation, ensuring it meets intended uses and complies with applicable regulations, current industry practices, and company procedures. The engineer will work closely with IT enterprise applications teams, business process owners, and key users to gather and document user requirements from stakeholders in both languages and manage validation activities of cross-functional teams. Responsibilities
Essential Duties and Responsibilities include the following. Other duties may be assigned.

• 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 organization 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:

• 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.