Business Analyst - R&D, PV & QA
Randstad Romania
Bucureşti, România
6 zile în urmă

Core Mission

Within the business domain described below, the incumbent is accountable for providing support and ensuring evolutions to support business improvements and regulation compliance for all applications in his / her scope and for successful project delivery.

Design, propose and implement new requirements and enhancement to the solutions, and lead the sustain model.

Act as a partner with the respective business process owners, as well as closely align with IT teams.

Business Analyst is responsible for functional support and continuous improvement of critical applications.

The overall objective is to understand the business need and translate that into value adding IT solutions.

  • Specialized in LIMS (Labvantage 8.3 moving to 8.6), EQMS (Trackwise 9,5,1) working as :
  • 1-IT contact for business demand management for LIMS, EQMS

    2-IT lead for LIMS, EQMS

    3-Responsible for 3rd line support relation

    4-System administration LIMS, EQMS

    Business domain scope : R&D, Quality and Pharmacovigilance

    Change and Support Activities

  • Integration of new solutions to existing IT landscape
  • Master data governance implementation >
  • isn't it something that should be handled globally and or you mean Propose proper Master Data giverannce for the systems / domain your are in charge?

  • Monthly Change Advisory Board meetings to drive evolutions / enhancements to the systems
  • Supervise the life cycle of applications within his / her domain (investment strategy, upgrade roadmap, decommissionning, ...)
  • Support delivery when needed (L2 / L3 support)
  • Establish Business partnership with user representatives to align our service level and activities with business expectations
  • Monitoring of maintenance and support activities and publishing of KPIs >
  • should fall into manager's responsibilities

  • Support audits and inspections from regulatory authorities
  • Project Related Activities

  • Plans, organizes and coordinates technical activities, participate to project plan and resources monitoring
  • Assess and execute on new regulatory requirement impact on systems
  • Ensure compliance to GxP regulation
  • Is responsible for end to end functional flows and propsoe adequate technical solutions to meet the need
  • Is in charge of solution testing and UAT
  • Consultant Management

  • Be the primary IT contact for any task executed by external consultants, such as design change request, interface or report setup.
  • Budget and Procurement

  • Comply with purchasing policies, Ensure Purchase Order in place with external consultants
  • Ensures sustain costs are included in appropriate budgets, participate to cost tracking versus budget
  • Work Experience

  • Minimum 5 Years in IT organization / software engineering
  • Experience of working for life sciences companies would be a plus
  • Good knowledge of Pharma process
  • Experience in GxP environment would be a plus
  • Education and Training

    University degree (University or Engineering School) in Computer Science or Information System or equivalent.

    Scrum expertise is a plus.

    Information

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