Saurabh Patil

Experience:

Onsite Client - Haleon

System Administration:

• Identify and drive system or process changes to enhance data quality, user experience, and compliance.
• Provide guidance and support for related initiatives, including system upgrades and enhancements in support of regulatory processes and obligations.
• Monitor system performance and ensure that performance or capability issues are resolved effectively.
• Collaborate with IT colleagues on system implementation and change control activities, including the development of iQMS IT quality documentation to support user acceptance.
• Create test scripts and reports for user acceptance testing.

System Reports:

• Support in managing the design, validation, and delivery of regulatory reports for compliance and departmental key performance indicators (KPIs).
• Ensure the timely delivery of ad-hoc and regular reports.

Data Compliance:

• Ensure the capture of high data quality regulatory data.
• Identify and communicate data errors and inconsistencies and drive data remediation initiatives as required.
• Manage the delivery of compliance reports required to support business stakeholders.

User Training and Support:

• Deliver effective system user training and promote compliant use of RIMs application.
• Maintain up-to-date process documentation, training materials, and user guides.
• Provide system administration, including user access management and roles.
• Offer day-to-day support to system users.
• Champion the importance of registration tracking within the organization through regular communication with global stakeholders.

Other Activities:

• Support other activities related to the Systems team as needed.

• During this internship period i prepared and submitted regulatory file applications and supporting documentation.
• I was responsible for requesting GMPs(GSK and 3rd party sites) and CPPs (English) for EU, India, Australia,Japan, Brazil, Anglowest Africa, Korea and Thailand for site Registration.
• I was actively involved in site registrations activities which is the initial part of product registration and comes under Module1.
• Handled various RTQs of Health Authorities.
• All the submissions are submitted through Veeva Vault software.
• Maintained and archived regulatory work in Veeva .
• Kept up-to-date with changes in regulatory legislation and guidelines.