Location: Braine L'Alleud and Anderlecht (Belgium) - Hybrid and up to 4 days in office as needed
Languages: English
Employment Type: Freelance
Start Date: ASAP
End Date: 2025-12-31(with potential renewal in 2026)
Context of the mission/Objective(s) of the job
Team info - size: The team consists of both full-time and part-time members, including foundation experts and compliance leads. Team of +/- 10 persons. What does the team do? The team is involved in a large-scale SAP S/4 HANA project, focusing on validation and compliance within the SAP environment.
Responsibilities
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 Client's 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 Client's IT Compliance Lead
Be fully available and committed during an Inspection/Audit preparation and defense
Be the deputy of Client's IT Compliance Lead for project assigned and share validation status with project team
Direct report to the Client's IT Compliance Lead on personal activities via weekly meeting
Collaborate with team members and vendors to ensure validation processes are followed.
Manage and interpret requirements from various stakeholders.
Ensure compliance with SAP validation standards.
Participate in team meetings and provide updates on project progress.
Work on-site four days a week, with some flexibility for remote work.
Requirements
Years of experience in the position / total
University degree/diploma, with Minimum of 3 years of experience in SAP validation
Total experience in related fields should be between 3 to 8 years
Experience working as a part of global teams
Must have
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's value and culture oriented
Experience in compliance/validation activities on mobile apps, web apps
Strong knowledge of SAP and SAP Validation processes
Excellent communication and people management skills
Ability to work autonomously and handle complex projects
Domain skills: SAP - FICO & any other modules (GxP or not) - GMP, Gdp and/or GLP experiences - SAP ECC - S/4 HANA
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: English (mandatory) - French and/or Dutch (nice to have)
Homeworking: - Hybrid role with four days a week on-site and 1 day home working