Software Management

Process Analyst Related Activities, Identifying, gathering, and analyzing business requirement to build efficient process through digital solutions for all functional areas within the organization. Trending and tracking of software concerns and reports to the respective stakeholders for further action. Works as interface/facilitator between the all the business and technical team for entire software related process (Requirement analysis URS -- designing development UAT – Validation -- Implementation). Evaluate proposed changes to validated computer systems and execute level of validation activities required. Prepare and execute software validation documents, tasks, activities, and deliverables for all GxP category system and work closely with Validation team and QA Compliance to ensure appropriate validation of GxP category systems to be completed within defined time commitments. Prepare, review software related documents (SOPs, Work Instructions, Manuals, URS, Validation deliverables, etc.) according to the organization SOPs and/or applicable regulatory requirements. Assist in the resolution of operational issues as needed, as well as the development of operational solutions.

Beta Testing, Basic data entry, validation, analysis, and cleaning knowledge, Agile Methodologies, Ability to conduct clinical research in compliance with the ICH GCP guidelines, Bug Life Cycle, Active Listener, Critical thinking and problem solving, Accepts Responsibility, Collaboration & Teamwork, Adaptability and Analytical skills, Bug Reporting, Agile Testing, Ability to grasp faster, Communication Skills, Attention to Detail, Adaptability to any environment of work, Data Migration, Ability to Handle, Cross Functional Collaboration, Clinical Operations, Deployment, Defect Reporting, Change Control Process, Application Management, Ability to communicate with efficacy, Adaptive Nature, Audit Trail, Ability to work long hours, often under pressure, defect management, Application Software, Computer System Validation, Bug Tracking, Ability to work independently, Change Control Management, CAPA

A minimum of M. Pharm, MSc. Computer Science, PG Diploma in Clinical Research, B.E. IT, B. Tech, M. Tech, B.E. Electronics and communications, or equivalent education unless demonstrated competence through work experience; Computer System Validation Certificate an asset; Knowledge of basic regulatory guidelines and computerized system validation guidelines for creating efficient process for all the functions.