The Senior Programmer Analyst performs or supports following activities: Validation for -PV system upgrades/hot fixes, client’s ad-hoc reports, gateways setup, client specific data migrations etc.
Assists department and develops metrics reports and techniques for improving process efficiencies and business performance. Serves as validation point of contact across the most challenging and complex PV projects. Acts as a consultant for the PV department.
Provides input into resource allocation/project estimates. Reviews and makes recommendations for process development and improvement.
Leverages the new capabilities with AI to bring efficiencies in the team.
What You'll Do:
Supports requirements gathering sessions with business stakeholders, translating business needs into detailed functional and technical requirements. Analyze requirements and collaborate with development teams to ensure accurate conversion into system design specifications, reports, and validated solutions.
Independently plan, author, execute, System Integration Testing (SIT), User Acceptance Testing (UAT), and Performance Qualification (PQ) protocols and scripts for validated GxP systems. Validate custom programs, listings, reports, and system enhancements in accordance with regulatory requirements and company procedures.
Serve as a subject matter expert (SME) for CSV activities, ensuring validation deliverables are developed, reviewed, approved, and maintained in compliance with applicable SOPs, industry regulations, and quality standards, including GxP and 21 CFR Part 11 requirements.
Drive continuous improvement initiatives by identifying opportunities to streamline, standardize, and automate business processes, improving operational efficiency, compliance, and data integrity.
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Author and maintain high-quality validation and SDLC documentation, including Validation Plans, Requirements Specifications, Risk Assessments, Test Protocols, Traceability Matrices, Validation Summary Reports, and change control documentation.
Develop and deliver end-user training, knowledge transfer sessions, and supporting documentation. Contribute to the creation and revision of SOPs, Work Instructions, and best practices to support validated system operations.
Develop the best practices documents based on the lesson learned from the deliveries and leverage it in upcoming validation deliverables.
Investigation and resolution of complex system issues, performing impact assessments, root cause analysis, and validation of corrective actions, enhancements, and system fixes in collaboration with business and technical teams.
Attend client vendor calls for the validation activity scope discussions and status handover.
Maintain current knowledge of evolving regulatory expectations, validation methodologies, industry trends, and emerging technologies related to Computer System Validation and Pharmacovigilance systems. Mentor junior team members and share best practices across the organization.
Support regulatory inspections, client audits, and internal quality audits by providing validation documentation.
Education & Experience Requirements:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years). Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.
Knowledge, Skills, Abilities:
Knowledge of CSV and Oracle Argus Safety system is an addon
In depth knowledge of Pharmacovigilance processes including applicable SOPs, ICH GCP, current pharmacovigilance regulations and local guidelines
Strong attention to detail
Comprehensive problem solving and innovative skills
Good written and verbal communications skills to effectively interface with teams and clients, including proficiency in the English language
Ability to independently and effectively organize and manage multiple assignments with challenging timelines
Ability to adapt and adjust to changing priorities
Ability to communicates effectively within a multi-disciplinary team
Ability to complete assigned tasks on time and within budget
Demonstrated positive attitude, enthusiasm toward work, and the ability to work well with others
Working Conditions and Environment:
Work is performed in remote environment with the electrical official equipment provided.
Why Join Us?
When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.
Apply today to help us deliver tomorrow’s breakthroughs.
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