Responsibilities :
- Identify and troubleshoot operational issues and system issues.
- Document business needs and identify solutions that align to overall business strategies. Review, analyse, and evaluate business systems for their applicability to identified user needs.
- Represents IT in collaboration with Quality Validation and business stakeholders to determine computer system validation (CSV) impact, requirements, and artifacts.
- Executes and facilitates GxP Computer System Validation activities for IT, including implementation, validation, maintenance.
- Responsible for CSV documentation including System Assessments, Validation Plan, User Requirements and / or Specifications, Testing Protocols and Scripts (UAT), Traceability Matrix, Validation Summary Report, etc.
- Support and maintain procedures and operational support processes.
Requirements :
- Customer Service oriented with attention to detail and quality.
- Reliable, consistent, proactive and accountable, adaptable to changes.
- SaaS IT systems configuration or software quality assurance background.
- Ability to effectively collaborate as part of a team yet can also work independently.
- Problem solving skills.
- Must be able to effectively prioritize and plan.
- Strong communication and facilitation skills to develop consensus, clarity, and decision-making.
- Understanding of technical IT issues to enable discussions with internal and external technical specialists.
- Experience working in a GxP environment(s) is required, including change control, change management, CSV.
- Experience with business process development and gap analysis, and business process mapping efforts.
- Experience with Veeva Vault (RIM, Quality, and / or eCTD) is highly preferred.
- Bachelor's degree in computer science, technology, operations, or related disciplines required.
- years in a pharmaceutical / biotech or related environment required.
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