We are recruiting a CSV Lead to join a leading Pharmaceutical company in the Walloon Region, Belgium. As the CSV Lead, you will have the chance to be at the forefront of ensuring compliance and continuous improvement within a GxP environment. You will be responsible for overseeing, governing, and enhancing corporate processes related to computerized system validation and access management.
This is a mission to start as soon as possible until the end of June 2027, with possible extension. The mission can offer two days per week remote working and the available budget is up to 650-784€ per day.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the CSV Lead will be varied however the key duties and responsibilities are as follows:
1. As the CSV Lead, you will maintain end-to-end oversight of the CSV and Access Management processes, ensuring alignment with regulatory requirements and internal standards.
2. As the CSV Lead, you will own and manage all related process documentation, including periodic review, updates, and gap analysis.
3. As the CSV Lead, you will identify risks and areas for improvement within the CSV and Access Management processes, leveraging feedback from audits, inspections, and internal stakeholders.
4. As the CSV Lead, you will communicate process changes, updates, and key performance indicators (KPIs) to all relevant stakeholders.
ROLE REQUIREMENTS:
To be successful in your application to this exciting role as the CSV Lead we are looking to identify the following on your profile and past history:
1. Relevant degree in a scientific or technical discipline.
2. Proven industry experience in computerized system validation and access management within a GxP environment.
3. A working knowledge and practical experience with regulatory compliance and process improvement.
Key Words: Corporate Process Owner / Computerized System Validation / CSV / Access Management / GxP / Regulatory Compliance / Process Improvement / Risk Management / Process Documentation / Inspection Readiness