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The Validation department is responsible for the development, implementation and improvement of different calibration and validation activities in accordance with cGMP guidelines.
You are responsible for:
• Writing and executing validation documentation in line with the Site Validation Master Plan.
• Daily Planning and coordination validation and qualification activities in your team.
• Managing deviations, changes and CAPA’s to ensure that these are well documented and that corrective actions are taken and followed-up.
• Coordination of calibration activities
• Supporting and participation in Corporate and Regulatory audits
• Master’s degree or equivalent in Engineering, Chemistry, Life Science, or other job related discipline
• 4 years' experience in Calibration/Validation/Quality systems - Project management experience
• Excellent communication skills, fluency in English
• Familiar with Quality Management and GxP Regulations
• Knowledge of Validation Methodologies
• Knowledge of Quality Systems, European and FDA regulations and cGMP
• Teamplayer, project proficiency and autonomy expected