MANIMARAN KANDASAMY
Chennai
Summary
Regulatory Systems and Publishing professional with strong experience supporting Life Sciences applications, regulatory submissions (eCTD, NeeS, PDF), and document management systems. Proven expertise in MyProcess, MyPress, Documentum, regulatory workflows, and SLA-driven production support.
Overview
15
15
years of professional experience
3
3
Certifications
2
2
Languages
Work History
Principal Technical Operations Engineer
Aris Global India Pvt Ltd
05.2023 - Current
Professional Experience:
- Administered and supported Life Sciences regulatory applications including MyProcess and MyPress
- Published regulatory submissions to global health authorities (FDA, EU) in eCTD, NeeS, and PDF formats
- Validated submissions using Lorenz/Lorence validator tools
- Created and managed regulatory applications, activities, products, programs, substances, and vocabularies
- Administered Documentum and resolved document management issues
- Installed patches and performed upgrades for MyProcess, and MyPress.
- Conducted monthly preventive maintenance and system health monitoring
- myPress overlay configuration, SIgnature configuration, etc
- Configured profiles, overlays, renditions, and template mappings
- Designed, maintained, and reviewed regulatory workflows
- Managed user accounts and resolved workflow-related issues
- Monitored indexing queues and investigated Elastic Search issues
- Analyzed system logs (message, error, query) for troubleshooting
- Wrote and executed SQL/DQL scripts for data analysis and issue resolution
- Ensured SLA compliance while managing incidents and service requests
Sr IT Service Desk Consultant
AMPLEXOR India Pvt Ltd
11.2018 - 05.2023
- Administered and supported Life Sciences regulatory applications, including MyProcess and MyPress
- Published regulatory submissions to global health authorities (FDA, EU) in eCTD, NeeS, and PDF formats
- Validated regulatory submissions using Lorenz/Lorence validator tools
- Created and maintained regulatory applications, activities, products, programs, substances, and vocabularies
- Administered Documentum and resolved document management and access issues
- Installed patches and performed upgrades for MyProcess and MyPress environments
- Conducted monthly preventive maintenance and monitored overall system health
- Configured system profiles, overlays, renditions, and template mappings
- Designed, maintained, and periodically reviewed regulatory workflows
- Managed user account creation and resolved workflow-related issues
- Monitored indexing queues and investigated Elastic Search–related issues
- Configured, administered, and troubleshot Active Directory, DNS, DHCP, and file servers
- Managed Active Directory environments (Windows Server 2003–2019)
- Performed user and computer account management, including creation, modification, and deactivation
- Managed security and distribution groups, group memberships, and FSMO roles
- Implemented and managed Group Policies based on customer requirements
- Monitored Event Viewer logs for server warnings and errors
- Performed Windows patching and monitored disk space availability
- Managed DNS records and created DHCP scopes
- Installed and configured network printers
- Provided remote support to end users
- Monitored ticketing systems and ensured issue resolution within SLA
- Analyzed system logs (message, error, and query) to troubleshoot application issues
- Developed and executed SQL/DQL scripts for data analysis and issue resolution
- Ensured SLA compliance while managing incidents and service requests
Sr. Professional Operations
IBM Pvt Ltd
04.2016 - 11.2018
- Maintained and supported Life Sciences pharmaceutical applications, including MyProcess and MyPress
- Administered MyProcess and MyPress environments, including patch installation and configuration updates
- Published regulatory submissions to health authorities in eCTD, NeeS, and PDF formats
- Performed monthly preventive maintenance and monitored system health
- Managed SLA compliance, ticket triage, and incident resolution
- Configured MyProcess profiles and implemented MyPress configuration changes
- Created and managed user accounts in MyProcess
IT Support Engineer
Nebula Computer Pvt Ltd
04.2011 - 04.2016
- Worked as IT Support Engineer in Nebula Computer Pvt Ltd from Apr-2011 to Apr-2016.
- Delivered application and system support for enterprise users
- Troubleshot software, system, and access-related issues
- Supported server operations and routine maintenance activities
Education
B.E - Computer Science and Engineering
Anna University
Tamilnadu04.2010
Skills
Life science Applications (myProcess, myPress)
Regulatory compliance, Regulatory applications, Regulatory Activites, QMS Documentations
Regulatory publishing like( Ectd, PDF, Nees, etc)
Documentum Administrator
Certification
Microsoft Certified IT Professional
ROLES & RESPONSIBILITIES
- Resolving publishing related issues such as document format, output folder, etc.
- Workflow related issues such as paused and Apaused workflow
- Periodical review workflow creation, Abort, resume of the documents
- Documents Workspace Features
- Document profile and Type configuration
- Life cycle configuration, workflows, Security.
- Document permission and assigning Roles
- Workspace Overview
- Document Management
- Document import, creation
- Document templates
- Document history tracking (audit trail)
- Access control
- Version control with versioning policy
- use of roles
- Use of compound documents (“virtual” documents)
- Creation of relationships between documents
- Use of electronic signatures
- Lifecycle automation
- Document annotations
- Maintaining & managing Life science pharmaceuticals Applications
- Maintaining and managing myPress and MyProcess administration
- Installing MyPress and MyProcess patch
- Document publishing to the agency(Ectd, Nees, PDF, Etc)
- Performing preventive maintenance on a monthly basis
- Master Data & Vocabularies
- RIM and Submission Expert
- Responsible for SLA and ticket Triage
- MyProcess Profile configuration changes
- MyPress configuration changes
- User account creation in myProcess
- Troubleshooting and resolving the system/solution related tickets
- Overlay configuration in myPress administration.
- Creation of Vocabularies
- Creation of Value list and data sources
- Creation of workflow and periodical review workflows
- Resolving workflow related ticket
- Responsible for JIRA ticketing process
- Troubleshooting the rendition and overlay issue.
- Analyzing the myPress and myProcess logs(Message, Error, Query logs related to the issue reported by the client)
- Checking indexing queue and status
- Elastic search related issues
- Resolving the incidents and service request within the SLA
- Resolving submission related tickets
- User and computer configuration changes
- Changes to Active Directory security and distribution groups
- Group policy management.
- Implementing Group policies as per the Customer request
- User password resets, user creation and deactivation, user group membership management
- Adding and removing domain controllers.
- FSMO Roles.
- Event viewer for warnings/errors on all Windows Servers
- Incidents and change implementing (Service Now / ITSM Tools / JIRA)
- Ticketing System monitoring and solving the ticket within SLA.
- Disk space Availability.
- Remote support for the end users.
- Creating Users in Active Directory.
- Windows Patching
- Installing, configuring network printers
Timeline
Principal Technical Operations Engineer
Aris Global India Pvt Ltd
05.2023 - Current
Sr IT Service Desk Consultant
AMPLEXOR India Pvt Ltd
11.2018 - 05.2023
Sr. Professional Operations
IBM Pvt Ltd
04.2016 - 11.2018
IT Support Engineer
Nebula Computer Pvt Ltd
04.2011 - 04.2016
B.E - Computer Science and Engineering
Anna University