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Implementation Consultant – Pharmaceutical Sector

About the role

• Execute SoftExpert Suite implementation projects for pharmaceutical companies and other regulated industries.
• Conduct the assessment, analysis, and mapping of processes related to Quality, Compliance, and Validation.
• Configure the platform in alignment with the business requirements identified within the project scope.
• Provide consulting services on the application of regulatory and quality management best practices.
• Conduct workshops, training sessions, and project follow-up activities for implementation projects.
• Guide solution configuration in accordance with applicable regulatory and operational requirements.
• Develop guidance and knowledge-transfer activities to support customer adoption of the solutions.

• Completed or ongoing higher education in Pharmacy, Biomedicine, Engineering, Technology, or related fields.
• Experience with software, management system, or ERP implementation projects.
• Technical knowledge of databases (SQL).
• Technical knowledge of system integration using REST, SOAP, and APIs.
• Technical knowledge of business process mapping and automation (BPM).
• Experience or knowledge of projects in the Life Sciences and regulated industries, such as pharmaceuticals, food and beverage, medical devices, or biotechnology.
• Knowledge of quality and regulatory compliance, including QMS, CSV, ANVISA, FDA, GxP, ISO, audits, and compliance.
• Experience or knowledge of controlled document management, CAPA, nonconformities, audits, traceability, and change control.
• Advanced English and/or Spanish for communication and project contexts requiring these languages.
• Availability for project-related travel or commuting.