Project Leader / TSO for eQMS / eDMS

Description

The IT project leader leads IT projects in his/her area from initiation to business value realization. The IT project leader designs and implements all information processes and systems needed to achieve sustainable goals setup for his/her project. The IT project leader acts as Technical System Owner eQMS/eDMS, maintains and develops the portfolio according to the IT and business strategy of the company.

Key Individual Accountabilities

• Leads projects to deliver on time, on specification and on budget.
• Engineer business processes.
• Prioritizes changes based on their value and alignment to business and IT strategy.
• Acts as eQMS/eDMS Technical System Owner and Subject Matter Expert.
• Manages eQMS/eDMS applications lifecycle in compliance with GxP regulations.
• Maintains process, technical and training documentation.
• Performs Testing and validation.
• Organizes functional forum and trains the trainers.

Key Shared Accountabilities

• With BPO’s and IT Partner, develops the IT system landscape and Communications according to Business and IT strategy.
• With project team, delivers the project on time, in budget and according to specifications.
• With other ITBP’s, integrates processes in other business domains.
• Integrates quality processes across platforms with the eQMS/eDMS team

Requirements

• Academic educational level, minimum B.Tech. or B.E./MBA is desired. Knowledge of the various eQMS/eDMS modules (document, training, deviations, CAPAs, audits, complains, etc..) business concepts and processes.
• Experience in change management and design of new processes in an international environment (>3 year)
• Experience in eQMS/eDMS  (8+ years), (preferable in MasterControl for eDMS, and Trackwise for eQMS.
• Experience in co-operation with different types of organization and different hierarchy levels
• General cGMP knowledge
• Management skills
• PMP or similar project management methodology.

Benefits

• Private Health Insurance
• Training & Development
• Performance Bonus