120 032
23 863
PHARMA INDUSTRY ROLE
The Validation CSV Consultant will play a crucial role in deploying and validating serialization systems, at customer sites around the globe. This position requires an in-depth understanding of the regulatory landscape of pharma, to ensure that all computerized serialization systems fully comply with rigorous international standards. The successful candidate will possess extensive expertise in pharmaceutical computerized system validation, demonstrating a strong command of data integrity principles and mastery in system validation lifecycle methodologies. This role involves direct collaboration with Nubinnos customers, offering a hands-on approach to implementing, validating, and optimizing serialization solutions tailored to meet their specific needs and regulatory requirements, ensuring seamless, compliant operations across the pharmaceutical supply chain.
1. Develop and implement comprehensive validation strategies for serialization systems, ensuring alignment with global regulatory requirements.
2. Execute risk assessments, validation planning, protocol development, testing, and reporting for computerized serialization systems.
3. Collaborate with IT, Engineering, Quality Assurance, and Operations teams to facilitate the integration and validation of serialization solutions effectively.
4. Offer expert guidance on serialization technology, regulatory compliance, and industry best practices to internal teams and stakeholders.
5. Lead training initiatives on validation protocols and procedures specific to pharmaceutical serialization for team members.
6. Maintain up-to-date knowledge of technological and regulatory developments in pharmaceutical serialization, applying insights to enhance validation processes.
7. Manage system validation documentation and records in strict adherence to data integrity and compliance standards.
8. Represent Nubinno during audits and inspections, defending validation practices and documentation to regulatory authorities.
1. Bachelor’s degree in Computer Science, Engineering, Pharmacy, or a closely related field.
2. A minimum of 3-5 years’ experience in computer systems validation within the pharmaceutical sector, knowledge of serialization process is a big plus.
3. Comprehensive understanding of global regulatory standards relevant to pharmaceutical serialization.
4. Proficiency in validation methodologies, GAMP 5 guidelines, and quality management systems.
5. Exceptional project management capabilities and the ability to lead multidisciplinary teams.
6. Strong analytical, problem-solving, and communication skills.
7. Demonstrated ability to work autonomously in a dynamic, fast-paced environment.
8. Experience in and knowledge of SAP Validation is a plus.
Nubinno is at the forefront of innovation in the pharmaceutical industry, committed to enhancing patient safety and supply chain transparency through advanced serialization solutions. We specialize in delivering cutting-edge technologies and services that ensure compliance, improve operational efficiency, and safeguard the integrity of pharmaceutical products worldwide. As we continue to grow, Nubinno is looking for an experienced Validation CSV Consultant specializing in pharma serialization to become an integral part of our team.