The CSV Analyst will be responsible for the following:
• Performs validation activities and deliverables on assigned Changes and Projects
• Proactively identify, in alignment with 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.
• value and culture oriented.
• 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
Must have:
• Strong knowledge of SAP and SAP VALIDATION processes.
• Excellent communication and people management skills.
• Ability to work autonomously and handle complex projects.
• Proficiency in English.
Ideal candidate:
• Experience with SAP ECC and SAP S/4 Hana.
• Familiarity with pharmaceutical manufacturing and quality management (QM) modules.
• Ability to manage multiple stakeholders and navigate complex organizational structures.
Language: