Beschreibung

In this role, you will be the key QA representative, guiding multidisciplinary teams to ensure quality assurance and compliance. Your day-to-day responsibilities will involve overseeing documentation, supporting qualification strategies, and participating in audits to uphold regulatory standards.

Anforderungen

• •Master’s degree in Engineering, Biotechnology, or related field
• •Minimum of 5 years relevant experience in GxP regulated pharmaceutical/biotechnology industry
• •Minimum of 3 years validation and qualification experience
• •Solid computer skills including MS Office
• •Analytical thinking and problem-solving attitude
• •Ability to work independently
• •Fluency in German and English, both written and spoken

Aufgaben

• •Act as the QA representative in multidisciplinary teams
• •Provide guidance on quality assurance practices
• •Ensure compliance with regulatory requirements
• •Oversee and approve qualification and validation documentation
• •Conduct risk assessments for equipment and facilities
• •Support the implementation of qualification strategies for equipment and utilities
• •Assist in the transition from project to commercial production phase
• •Ensure compliance of quality systems with regulatory expectations
• •Establish and improve quality procedures in your area of responsibility
• •Continuously enhance allocated quality systems
• •Support changes and corrections within your area
• •Participate in audits and inspections related to your responsibilities

Tools & Technologien