Technical / Functional Skills

• Experience in administering and troubleshooting the TrackWise digital platform with one or more modules such as Change Management, Quality Event Management, Complaint Management, and Internal/External Audit Management.
• Experience in Change Management is mandatory.
• Experience in administering and troubleshooting TrackWise Digital application
• Strong understanding of Salesforce platform, Salesforce Administration
• Knowledge of Change Management, Deviations, and CAPA.
• Understand the workflows of business process and suggest improvements as required
• Must have exposure to GXP compliance systems including 21 CFR part 11 compliance. 
• Strong understanding and desire to manage GxP systems following computer system validation processes and procedures.
• Coordinate with cross-functional stakeholders such as the System Owner, IT Infrastructure teams, Validation, Business Process Owners, and Software vendors, etc.
• Contribute to the support and maintenance of operational documentation including SOPs, Work Instructions, manuals, and training materials for end users and system administrators.
• Own and perform Annual and Periodic reviews for the TrackWise Digital applications following the defined policies and procedures.
• Provide end-user support including troubleshooting problems at the application level (including working with vendors to resolve issues).
• Have Life sciences or pharma domain knowledge in supporting GxP applications
• Strong design, analytical and problem-solving skills
• Excellent presentation and organizational skills.
• Excellent communication skills (both written and verbal)

 

Roles & Responsibilities

• Trackwise Digital support projects (L2 &L3)
• Mentor and build team
• Client Liaoning
• Provide end-user support including troubleshooting problems at the application level (including working with vendors to resolve issues)
• Coordinate, design & configuration