Beschreibung

You will drive quality excellence by leading validation projects and ensuring strict regulatory compliance. Your day-to-day involves solving complex deviations and representing the organization to global authorities.

Anforderungen

• •Technical background, ideally Mechanical Engineering degree
• •Validation and qualification background in pharma
• •Knowledge of GMP, ISO, FDA regulations
• •Experience in manufacturing, QC, and projects
• •Ability to use statistical analysis tools
• •Quality mindset and risk-based decision-making
• •Leadership, teamwork, and communication skills
• •Good command of English

Aufgaben

• •Manage quality assurance for company projects
• •Focus on qualification and validation processes
• •Lead and support cross-functional quality activities
• •Document decisions with clear justifications
• •Apply FDA, GMP, and ISO compliance standards
• •Prepare accurate qualification and validation documentation
• •Maintain record traceability and integrity
• •Plan and prioritize validation project phases
• •Conduct risk assessments and develop protocols
• •Investigate deviations using structured problem-solving
• •Analyze process data with statistical tools
• •Represent the company to regulatory authorities
• •Manage qualification strategies with customers
• •Support CAPA, change control, and complaints
• •Drive continuous improvement initiatives

Tools & Technologien

Benefits