About the Role: We are seeking a dedicated Validation Specialist to join our RTPDM team, focusing on real time process data monitoring for vaccine production across multiple sites. This role is pivotal in ensuring the accuracy and compliance of data used in manufacturing processes, ultimately supporting GMP decisions and enhancing production efficiency. Key Responsibilities: Project Collaboration: Work closely with MSAT users and stakeholders to put manufacturing data into practical use for process and production optimization. Platform Utilization: Utilize PI Vision to explore relevant vaccine production processes and demonstrate the value of process parameters. Data Validation: Validate transformed data and ensure it meets GMP standards, enabling informed decision making. Guideline Review: Review and update existing validation strategy guidelines, transforming them into official documentation (annex, template, or SOP). Documentation: Develop and refine templates, color codes, and decimal numbers for validation strategies. System Expertise: Leverage OSI PI Vision to access and interpret stored data, understanding its evolution over time. Deliverables: Collect and analyze existing practices and documentation Write and present change control documents to the board. Develop and approve SOPs and change management documentation. Use VEEVA for results storage and documentation. Qualifications: Educational Background: Degree in Life Sciences, Pharmaceutical Sciences, Engineering, or a related field. Experience: Proven experience in pharmaceutical manufacturing, particularly in vaccine production and GMP compliance. Technical Skills: Proficiency in OSI PI Vision and data analysis. Documentation Skills: Strong ability to write SOPs, change controls, and validation documents. Project Management: Experience in managing cross functional projects and collaborating with site teams. Communication: Excellent written and verbal communication skills; proficiency in French and English is mandatory. Why Join Us? Impactful Work: Play a crucial role in ensuring the quality and compliance of vaccine production processes. Collaborative Environment: Work with a dedicated team of professionals committed to excellence in pharmaceutical manufacturing. Professional Growth: Opportunities for learning and development in a dynamic and innovative field. Amaris Consulting is proud to be an equal opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.