Job Description:
Support the validation and compliance aspects of remediation projects in regulated environments.
Key Responsibilities:
- Validate remediation activities to ensure compliance with GxP regulations.
- Analyze the impact of remediation actions on validated state.
- Define and document validation strategies, including CSV risk assessment, test strategy, and acceptance criteria.
- Support the creation or update of validation deliverables, such as plans, risk assessments, and test plans.
Required Skills and Qualifications:
- Minimum 3 years of experience in CSV in regulated environments (GxP, ALCOA+, Data Integrity).
- Experience with laboratory instruments and associated software (standalone or networked).
- Knowledge of IT system lifecycle, including OS upgrades, software patches, and hardware obsolescence.
- Fluency in French oral communication, for interaction with on-site teams.
- Rigorous, autonomous, and reliable, with ability to assess situations and propose actionable plans.
Benefits:
This role offers a permanent contract and the opportunity to work on challenging remediation projects in a regulated environment.