IT CSV Medior

Role: IT CSV – Medior

Location: Braine L’alleud (Belgium) Hybrid 2 days in office

Deadline for submitting CV's: Asap

Client: UCB

Description:

Job Summary:

The Medior CSV Analyst will be responsible for the following:

• Performs validation activities and deliverables on assigned Changes and Projects

• Proactively identify, in alignment with UCB IT Compliance Lead, the validation approach and deliverable list.

• Responsible for authoring, facilitating, reviewing any CSV deliverable as per the RACI matrix: authors amongst

• others: Validation requirement assessment, Validation Plan and Report, Test protocols and report, Traceability

• matrix. Facilitate all other deliverables

• Responsible for the sequencing and monitoring of deliverable completion

• End-to-end ownership and following-up pro-actively on validation documentation and testing activities

• Coordinate test execution in collaboration with IT system owner, Business Owner and testing team

• Create test protocols and report (IQ/OQ/PQ/MQ)

• Support the writing and execution of test scripts (IQ/OQ/PQ/MQ), with IT and business stakeholders

• Creates, facilitates and monitor Deviations and related actions (investigations, CAPA…)

• Escalate any issues or delay to the UCB IT Compliance Lead

• Be fully available and committed during an Inspection/Audit preparation and defense

• Be the deputy of UCB IT Compliance Lead for project assigned and share validation status with project team

• Direct report to the UCB IT Compliance Lead on personal activities via weekly meeting

• Be part of a weekly activities review meeting with associated UCB IT Compliance Lead
  
  

Job Qualifications:

• University degree/diploma, with 3 years of equivalent experience.

• Experience working as a part of global teams.
  
  

Specific Skills:

• Good experience working and handling CSV Projects, minimum 3 years.

• Diplomatic, good communication and negotiation skills.

• Good English speaking/writing skills, French speaker would be a plus.

• Stakeholder management. Proactive and motivated.

• Should be able to work in autonomous mode.

• Client value and culture oriented.

• Experience in compliance/validation activities on mobile apps, web apps.
  
  

Domain Skills:

Required:

• General Pharma application

• GPVP eg adverse event reporting (Argus, ArisG, Veeva Safety)

• GCP eg. Clinical trail monitoring (CTMS..)

• General Pharma (QMS, Learning, Testing system, medical applications)

• Veeva knowledge is a plus
  
  

Nice to have:

• Infrastructure components and platforms:

• Monitoring tools

• Identity and Access Management

• Communication (skype, exchange, office 365)

• Cloud platforms (azure, Amazon)