Overview
Configure, support and maintain packaged or SaaS applications for Regulatory IT systems in a GxP-regulated Life Sciences R&D environment, owning day-to-day operational support, incident and problem management, and small-scale change work.
What you'll do
- Lead day-to-day operational support for Regulatory IT systems, ensuring high availability and reliability.
- Investigate issues, drive root cause analysis and resolution as a hands-on problem solver.
- Own Incident Management and Problem Management processes in alignment with ITIL best practices.
- Ensure timely communication, escalation and closure of incidents impacting business operations.
- Coordinate with vendors, internal IT teams and business stakeholders to resolve system issues efficiently.
- Support GxP-regulated applications, ensuring adherence to validation, compliance and data integrity requirements.
- Assist with audit readiness, including documentation support, evidence collection and response coordination.
- Ensure operational activities comply with SOPs, change control and regulatory expectations.
- Provide operational support for Document Management Systems (e.g., Documentum) and publishing/submission systems such as TRS, Lorenz, Axway and related platforms.
- Support job monitoring, queue management and system health checks to identify and prevent issues proactively.
- Perform initial triaging of system performance issues, including infrastructure or cloud-related (AWS) impacts, before escalation.
- Serve as a key point of contact for operational matters with external vendors.
- Communicate clearly with stakeholders on system status, incidents, risks and remediation plans.
- Manage and support small-scale projects, including minor upgrades, enhancements and operational improvements.
- Participate in change management, including impact assessments, implementation coordination and post-change validation support.
- Contribute to continuous improvement initiatives to enhance system stability, performance and support processes.
- Gather requirements and implement application enhancements with cross-functional teams.
- Monitor application performance, troubleshoot issues to minimize downtime, and document configuration changes and system updates.
- Assist junior team members by sharing knowledge and guidance on application support tasks.
What you'll need
- Minimum 3 years of experience in Life Sciences Research and Development.
- Proficiency in Life Sciences Research and Development.
- Strong problem-solving skills with a hands-on, proactive approach to issue resolution.
- Excellent communication and collaboration skills, with the ability to work effectively with diverse stakeholders and vendors.
- Practical experience with ITIL processes, particularly Incident Management and Problem Management.
- Experience managing or supporting small-scale IT projects in an operational or regulated environment.
- Experience configuring and supporting packaged or cloud-based software applications.
- Familiarity with standard tools, application programming interfaces and low-code platforms for application customization.
- Ability to manage software release cycles and ensure system stability and performance.
- Strong problem-solving skills to address technical challenges and optimize application functionality.
- 15 years full-time education.
Nice to have
- Experience with SSO configuration and user access management.
- Ability to perform basic troubleshooting and data validation for integrations using REST / AS2.
- Understanding of network-related activities, network tunnels, file share, AWS VPC, job scheduling, queue management and batch processing.
- Exposure to AWS or cloud-based environments, with the ability to perform initial triaging of infrastructure or performance-related issues.
Details
- Based at the Pune office.
- Expected to perform independently and become a subject matter expert.
- Required to actively participate and contribute in team discussions.
Read the full description and apply on the company’s own careers page.