Beschreibung

You manage compliance and quality assurance tasks, ensuring that regulatory standards are met while collaborating with various departments to resolve issues and maintain accurate records of facility assets.

Anforderungen

• •Bachelor's or master's degree in Engineering
• •Minimum 2 years working experience
• •Highly knowledgeable in cGMP regulations
• •Know-how of qualification and mapping requirements
• •Good understanding of Quality tools
• •Effective communication skills in German and English
• •Ability to work collaboratively with others
• •Ability to work on own initiative
• •Ability to organise and prioritise workload
• •Ability to logically fault find efficiently
• •High level of attention to detail
• •Demonstrate pride in work
• •Confident handling of quality systems
• •Strong analytical and problem-solving skills

Aufgaben

• •Create and update standard operating procedures (SOPs)
• •Develop qualification, re-assessment, and re-mapping documents
• •Prepare and execute re-mapping and initial qualification of rooms and devices
• •Conduct testing and manage compliance assessments
• •Oversee creation of deviations, investigations, and impact assessments
• •Participate in internal and external audits
• •Execute findings from audit responsibilities
• •Serve as point of contact for quality issues
• •Collaborate with departments to resolve quality issues
• •Perform periodic software reviews
• •Monitor and maintain records of facility assets using IBM Maximo

Tools & Technologien

Benefits