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
