Analyst

As part of the “Global Service Operation Center & Compliance” department in “Information Technology” you will support the IT domains operationally regarding the ensuring, modification, lifecycle management and relationship management of the  Computerized System Validation and Infrastructure Qualification of Computerized Systems. By performing complex process analysis, monitoring, reporting and governance you will support continual improvement activities for the “Validation and Infrastructure Qualification Process”. You will have to establish relationships with the IT domains and pro-actively support them to understand their process performance, indicators, and improvement areas. Work closely with all stakeholders eg. Corporate Quality Assurance and IT Infrastructure Qualification functions, IT Service Delivery Managers, Subject Matter Experts and Application Owners to ensure the smooth running of IT Application and Services.

Specifically, you will:

• Support Validation and Infrastructure Qualification of Computerized systems (Operating Systems, Applications, Databases, Network, Servers) and oversee end-to-end process enforcement.
• Support Application Validation and create relevant documents (Operating Systems, Databases, Network, Servers) are created, updated, and reviewed on the defined IT Quality standards (Computer Validation) and on time on the regular bases.
• Support Computerized System Validation and IT Infrastructure Qualification and create relevant documents (Operating Systems, Databases, Network, Servers) are created, updated, and reviewed on the defined IT Quality standards (Computer Validation) and on time on the regular bases.
• Provides input to IT Management for Compliance and risk-based approach on the Qualification state of the respective IT systems.
• Support and participate internal and external Audit activities in scope of the Computer Validation and IT Infrastructure Qualification dimension of specifically regulated systems.
• Identifies “Computer Validation and IT Qualification Management” process key performance indicators (KPIs), establishes KPI baselines and targets and guides process, tools, and people to meet the targets.
• Observer and provide feedback to team management on the “IT Qualification Management & IT Quality Management” process improvement opportunities, where automation and self-service can increase efficiency in terms of reducing cost and time.

Qualifications:

• Academic Degree or equivalent and minimum 4 years of experience
• Preferably to have ECA Certified Computer Validation Manager certifications as follows.
  • Cloud Computing in a GxP Environment
  • Computerized System Validation: Introduction to Risk Management
  • Computerized System Validation: The GAMP 5 Approach
  • IT-Infrastructure Qualification and Operation
• Solid understanding and experience on the fraying documentation (URS, FRS, DS etc.) of the Validation of Corporatized systems is must.
• Strong knowledge and experience on the GAMP 5 processes mandatory and ANNEX 11 experience is a plus.
• Outstanding communications skills, able to translate technical diagnosis into business relevant context and articulate business impact to all levels of the organization.
• Good Understanding of different ITIL processes and their interactions with each other. ITIL v3 foundation or higher certification preferred.
• Must have 7-8 years actual/fresh hand-on field experience.
• Exposure to service management and incident management tools
• Demonstrated ability to effectively work with multiple cross-functional teams and bring diverse groups to consensus
• Ability to write clear documentation and communicate complex information simply and accurately to both technical and non-technical audiences
• Demonstrated focus on customer support and results-oriented improvement efforts