Beschreibung
Reporting to the Validation and Metrology Manager, you ensure the qualification and validation of equipment, processes and systems. You intervene throughout the entire lifecycle of validation activities within a demanding regulatory framework.
Validation/ Qualification Specialist
Our client is an international company in the pharmaceutical sector. It stands out for its expertise in the development and production of innovative solutions.
Responsibilities
- Define qualification/validation strategies based on a risk-based approach
- Write, coordinate and execute validation protocols
- Ensure the maintenance of the qualified status of systems and equipment
- Manage documentation (procedures, protocols, reports)
- Manage external service providers (planning, monitoring, document review)
- Participate as an expert in investigations, deviations and CAPA
- Contribute to projects for acquiring new equipment
- Assess the impact of changes on validated systems
- Work closely with engineering, production, quality and maintenance teams
- Participate in regulatory audits and inspections
Candidate Profile
- Higher education (engineer or university degree)
- Experience in validation within the pharmaceutical or medical device industry
- Mastery of qualification/validation processes and lifecycle
- Good knowledge of GMP and ISO 13485 standards
- Knowledge of reference frameworks such as GAMP5, ICH, ISO 14644, ISO 11607 is a plus
- Excellent writing skills and document control rigour
- Analytical mindset and ability to propose improvements
- Comfortable with IT tools
- Autonomy, organisation and team spirit
Conditions and Benefits
- A dynamic and quality-oriented environment within the scope of a temporary assignment
- Varied technical projects with high added value
- Attractive conditions with prospects for advancement