Senora Consulting

Summary
Having experience with implementing and maintaining systems within different kind of environments: analyses and optimization of business processes,  project management, system development & configuration, computer system validation, creation and review of procedures, change management, end user training and system management.

Experience

ICT Project Management, Business Proces Analyses and System Support

(Sr.) Project Manager system implementations:

• Project management of multiple projects in parallel by teams consisting of system developers, business analysts, (offshore) master data consultants, business process subject matter experts, validation/test consultants and/or infrastructure support.
• Responsible for e.g. project finances, project timelines, resources, deliverables, quality, and solving problems and conflicts.
•  Primary contact person between departmental management, software-, hardware-, and infrastructure implementation project teams, and third parties.
• Ensuring teams implement systems according to strategy, (system) requirements and procedures as defined by (corporate) head offices.
• Financial responsibility for initial budget estimation, budget forecasting and monitoring budget statuses in favor of monthly invoices and management reports. budgetten voor maandelijkse facturering en financiële rapportages.
• Managing external parties and consultants.
• Involvement with defining the digital business strategy and road map.
  

(Sr.) Business Analyst:

• Defining the current business processes and system use by the different end users within a company (departments, sites).
• Identifying, analyzing, and drafting process-, and system related improvements.
• Proposing future, harmonized, standardized processes.
• Drafting transformation road maps.
• Implementing process-, and system related improvements:

Computer System Validation (CSV) Consultant:

• Creation, review and approval of CSV related deliverables like the Validation Plan, Validation Protocol, Tests Scripts, and the Validation Report.
• Validation of new functionalities before these are released to the client and/or end-users.
  
  

(Master Data) Team Lead:

Managing Teams; Team size varied from 3 - 10 developers, business analysts and other subject matter experts.

Pharmaceutical Industry Specific

Project Management:

• Responsible for a portfolio of development-, implementation-, and maintenance projects related to Quality-, and Business Systems within cGxP environments.
• Primary contact person between local site management, production / operations, quality departments including laboratory, software-, hardware-, and infrastructure implementation teams, third parties and the corporate headquarters.
• Managing multidisciplinair teams.
• Responsible for e.g. project finances, project timelines, resources, deliverables, quality, and solving problems and conflicts.
• Responsible for the development of project management documents, system-, hardware-, and user requirements, functional-, and system design specifications, and validation documentation.
• Team-, and end-user training.
• Change management.
  
  

Business Analyst / Application Specialist:

• Initial site assessments to decide if a site and/or the system is ready for an implementation.
• Business process analysis: identifying, analyzing, drafting and implementing of business or system improvements as part of Corrective Action and Prevention Action (CAPA) investigations and/or risk assessments, or as part of process, operational excellence activities (Lean Six Sigma).
• (Hands-on) computer system validation support, system configuration, and master data entry.
• Daily support and maintenance of quality systems including initiation, planning and management of continuous development activities.
• Representing the system during investigation and audits by internal and external parties like clients and the FDA.
• Creation and review of procedures and manuals.
• Creation, coordination and providing end-user training.