Regulatory Operations Expert
vor 2 Monaten
Job Title: Regulatory Operations Expert
We are seeking a highly skilled Regulatory Operations Expert to join our team at FERCHAU GmbH. As a key member of our operations team, you will be responsible for ensuring the regulatory compliance of our facilities and systems.
Key Responsibilities:
- Ensure the regulatory operation of qualified facilities, following internal and external guidelines and regulations.
- Coordinate maintenance activities and technical changes to ensure compliance with regulatory requirements.
- Assist in the qualification of systems and equipment to ensure they meet regulatory standards.
- Prepare and maintain documentation according to regulatory standards, including GxP documentation.
- Participate in technical projects and quality assurance activities to ensure regulatory compliance.
- Utilize SAP DVS for document management and tracking.
Requirements:
- Bachelor's degree in Engineering or equivalent experience.
- Experience working in regulated environments, such as pharmaceutical manufacturing or quality assurance.
- Hands-on experience with clean rooms and refrigeration units, including maintenance and operation.
- Proficiency in document preparation and GxP documentation, including SAP and document management tools.
- Strong communication skills and stakeholder management, including fluency in German and English.
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