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Regulatory Compliance Specialist
vor 2 Monaten
About the Role
We are seeking a highly skilled Qualification Lead to join our Business Acceleration team at UCB. As a key member of our team, you will be responsible for ensuring the qualification of installations and systems in line with procedures, regulatory requirements, and user needs.
Key Responsibilities
- Develop and execute qualification strategies to ensure compliance with regulatory requirements.
- Lead risk assessments and prepare qualification documents to ensure the quality and integrity of our installations and systems.
- Ensure proper qualification of GMP installations and utilities, and coordinate with external partners to maintain schedules.
- Perform periodic requalification and update necessary files to ensure ongoing compliance.
- Improve qualification processes and documentation to enhance efficiency and effectiveness.
- Lead and participate in relevant projects to drive business growth and improvement.
- Serve as a Subject Matter Expert (SME) in qualification activities to provide guidance and support to colleagues.
- Follow cGMP requirements and complete training to ensure ongoing compliance.
- Use approved documents and provide accurate results to ensure the quality and integrity of our installations and systems.
- Participate in audits and handle deviations and Change Controls as SME to ensure ongoing compliance.
- Actively take part in the application of the HSE policy (Health, Safety and Environment) to ensure a safe and healthy work environment.
Requirements
- BS in Engineering, Science, or equivalent technical degree.
- In-depth knowledge of commissioning and qualification activities, including risk analysis expertise.
- 5 years in pharmaceutical and/or biotechnological manufacturing.
- 5 years in qualification of equipment in controlled areas.
- In-depth knowledge of cGMPs and regulations linked with biotech/pharmaceutical manufacturing.
- Strong organizational skills.
- Excellent communication skills, for communicating with internal and external partners, with a good level of spoken and written French and English (B2 minimum).
