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 the 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 IT Compliance Lead
Be fully available and committed during an Inspection/Audit preparation and defense
Be the deputy of IT Compliance Lead for project assigned and share validation status with project team
Direct report to the IT Compliance Lead on personal activities via weekly meeting
Be part of a weekly activities review meeting with associated IT Compliance Lead
Requirements
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.
Experience in compliance/validation activities on mobile apps web apps.
Domain Skills:
SAP o FICO & any other modules (GxP or not) o GMP GDP and/or GLP experiences o SAP ECC o S/4 HANA