ITSoli - System Manager - SaaS Submission Management - Life Science Domain
2 months ago
Designation : Systems Manager - SaaS Submission Management (Life Sciences Domain)
Qualification :
- Bachelor's degree in computer science, Information Technology, Life Sciences, or a related field.
Experience (Required) :
- Minimum 5+ years of relevant working experience with systems management, within a SaaS product-based environment preferably in the Life Sciences domain.
- Strong understanding of GxP regulations, validation processes, and compliance requirements is required.
Work Location : Bangalore (Karnataka)
Work Mode : Hybrid (Should be ready to work from office as in when required)
Working Hours : 7 : 00 PM - 4 : 00 AM / 8 : 00 PM - 5 : 00 AM (PST Hours)
Position Overview :
The Systems Manager will play a crucial role in managing and maintaining the company's SaaS-based submission management platform. This role requires an in-depth understanding of GxP applications and validation processes, as well as the ability to manage system configurations, user access, and handle release and change management effectively. The Systems Manager will ensure the platform remains compliant, secure, and optimized for all users.
Key Responsibilities :
1. User Management & Access Permissions Configuration :
- Add and remove users within the SaaS platform.
- Maintain and update user roles and profiles according to company policies.
- Ensure that user access aligns with compliance requirements, especially within the Life Sciences domain.
- Configure and manage access permissions to ensure data security and compliance with GxP standards.
- Regularly review and update permissions to reflect organizational changes and security best practices.
- Conduct periodic audits to ensure all access permissions are appropriate and compliant.
2. Release Management :
- Thoroughly review release notes provided by the SaaS vendor to assess any potential impacts on the current system implementation.
- Collaborate with stakeholders to understand the implications of new features or changes introduced in vendor releases.
- Test and validate new releases in a controlled environment before rolling them out to production.
3. Change Management :
- Develop and implement change management plans to ensure smooth adoption of system updates and enhancements.
- Coordinate with cross-functional teams to manage the impact of changes on business processes and operations.
- Maintain documentation related to changes, ensuring traceability and compliance with GxP requirements.
4. System Validation :
- Ensure all system changes and updates are validated according to GxP standards.
- Develop and maintain validation protocols, test cases, and other necessary documentation.
- Work closely with Quality Assurance to ensure all validation activities are completed and documented.
5. Compliance and Audit Support :
- Ensure the system complies with all relevant regulatory requirements, including GxP.
- Support internal and external audits by providing necessary documentation and system information.
- Implement and monitor compliance measures to mitigate risks.
Required Key Skills :
1. Minimum of 5 years of experience in systems management, within a SaaS product-based environment preferably in the Life Sciences domain.
2. Strong understanding of GxP regulations, validation processes, and compliance requirements.
3. Experience with user management, access control, release management, and change management in a regulated environment.
4. Excellent problem-solving skills, attention to detail, and the ability to manage multiple priorities.
5. Strong communication and collaboration skills, with the ability to work effectively with cross-functional teams.
Preferred Skills :
1. Experience with submission management platforms or other Life Sciences SaaS products.
2. Knowledge of regulatory submission processes and related software tools.
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