Company Description

AltiusHub provides cloud-based serialization track and trace and warehouse management software solutions. Our SaaS platform enables companies to monitor their products throughout their entire lifecycle, from production to final sale. Utilizing cutting-edge technology powered by Artificial Intelligence (AI) and Machine Learning (ML), our platform delivers actionable insights for diverse stakeholders, including plant and warehouse managers, production heads, and regulatory authorities. AltiusHub is at the forefront of advancing digital supply chain management to ensure transparency and efficiency.

Role Description

This is a full-time on-site role located in Hyderabad. The CSV (Computer System Validation) professional will be responsible for ensuring that software systems meet compliance standards, creating and reviewing validation documentation, and conducting risk assessments. Key responsibilities include collaborating with cross-functional teams, overseeing system testing, and supporting audits. The role will involve maintaining validation protocols in alignment with industry and regulatory requirements.

Qualifications

• Experience in Computer System Validation (CSV) processes, including creating, executing, and managing validation protocols
• Strong knowledge of regulatory compliance standards, such as FDA 21 CFR Part 11 and GAMP 5 guidelines
• Proficiency with Quality Assurance, Quality Management Systems, and risk assessment methodologies
• Technical understanding of software systems, including cloud-based solutions, Artificial Intelligence (AI), and Machine Learning (ML)
• Strong written and verbal communication skills and the ability to collaborate effectively with cross-functional teams
• Detail-oriented with excellent problem-solving and organizational skills