Senior Analyst (QMS)

Technical/Functional Skills8-10 years' Sound experience with Trackwise - Configuration, Coordinator Configuration, Crystal Reports Development and Web Services development required.Perform configuration in Trackwise modules like Team Access, Web Admin, Coordinator, Migrator (Designing workflows, Admin queries, Dynamic queries, Admin triggers, Notifications, PR/Selection Import utilities)Perform troubleshooting and resolve L2 & L3 support issues such as record issues, workflow configuration issues, access issues, Perform regular support tasks such as Master data import and creation of user access.Perform detailed data analysis, RCA, data validation and identify data quality issues and Keep required stakeholders proactively informed on progress all support related activities and conduct regular ticket review analysis, suggest and implement continuous improvements.Development experience on Trackwise Quality management software system Experience working with workflow configurations and resolving related issues when the records are stuck Experience working with PR Import Selection Worked on Trackwise Team Access Web Admin component.Candidate should have good understanding of interfaces connected with Trackwise (i.e. SFDC, ETL, and SAP. Etc)Candidate should have basic knowledge of Windows Server.Good technical knowledge in SQL, Trackwise DB structure and Crystal reports designFamiliar with Business processes like Complaint, Deviation, Audit, CAPA etc.Good knowledge of Software Development Life Cycle, Change and Problem Management.Excellent English communication skills, both written and oral, additional languages would be a plus.GxP, 21 CFR Part 11, and Life sciences domain knowledgeActively participate in all the project related meetings and planning activities.Experience Required

8-10 Years

Roles & Responsibilities

Customer facing role, proactively collaborate with customer, understand & analyze requirements, map customer's business operations, proactively recommend customer on requirements, challenges, etc. collaborate with Onshore team, explain and transform requirement to functional specifications, Train technical team on new requirements. Manage SLA's

Generic Managerial Skills

Contribute subject matter expertise during root cause analysis and problem-solving activities during system outagesIdentify, review, evaluate and analyze help to implement all applicable system modifications, enhancements, or upgradesSupport multiple company sites for both global and site-specific scientific systemsCommunicate with the Infrastructure Team for troubleshooting support issues and system implementation.