Compliance coordination LC Cyber Security & physical assets
Contracting – Brabant Wallon
Your responsibilities:
- Perform mapping of current situation of qualification/validation status in CMC Dev
- Evaluate risk and define remediation plan with system owner
- Complete and maintain tracker DT with prioritization
- Project Management support for physical assets topics
- Drive meetings to support Project
- Update documents (sops, process, assessment, slides …) identified in project
- Good knowledge qualification and validation process, IT compliance, GMP knowledge, data Integrity principles
- Drive remediation plan, coordinate and finalize actions
- Drive dashboard for core team for Dev entities
- Interaction transversal entities (IT, Manufacturing, biological, chemical, QA, outsourcing Lead …)
- On site assignment
Your profile:
- Master/Bachelor: Biology, chemical, IT
- Min years’ experience required: 2-3 years
- Experience Cyber security and IT compliance/validation
- Experience project Management and compliance
- Experience qualification / validation process
- Experience Data integrity concept and quality system
- International experience a plus
- Key technical backgrounds: small molecule chromatography (HPLC/UHPLC/GC) and detection techniques (UV/Vis, MS), electrophorese, USP/EP Pharmacopoeias, RMN, …
- Mandatory skills: team player, exp. in a similar position/environment, compliant/rigorous
- Fluency in French and English
Our offer:
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]
