Analytical Validation Manager

at  Eurofins Netherlands BioPharma Product Testing

Company Description
Business Unit Eurofins PROXY is part of the international operating Eurofins Scientific and is a GMP Quality Control laboratory, where analytical chemical testing of raw materials, drug substances and drug products is performed. A large part of this work comprises routine compendial testing. However, for new products, formulations or monographs clients require development or validation of analytical methods.

Job Description

• Maintaining contacts with customers;
• Drawing up project plans in consultation with Sales and/or the Manager Project Management;
• Assist in the preparation of quotations for projects;
• Translate customer demand into protocol and/or work plan;
• Overall management of the assigned projects including coordination, planning and communication;
• Management and execution of various stability studies according to GMP standards and procedures;
• Review and interpretation of generated data;
• Conducting investigations into complaints and deviations and reporting this to QA;
• Taking care of corrective and preventive measures in the event of complaints and deviations;
• Support during internal and external audits.

QUALIFICATIONS

• You have a MSc or BSc in analytical chemistry, biochemistry, or organic chemistry;
• You have Experience in validation of analytical methods, preferable in biotechnology or pharmaceutical industry;
• You are familiar with relevant ICH guidelines;
• You are independent, enthusiastic, goal-oriented, efficient, and accurate, and enjoy working in a fast-paced environment;
• You can run several projects in parallel and working in a flexible way;
• You enjoy working in a team and you welcome and use feedback as an opportunity to learn and grow;You are fluent in English (basic knowledge of Dutch is an advantage, but not a requirement).
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  Additional Information

WOULD YOU LIKE TO KNOW MORE?

For questions regarding the position, please follow the link below ‘I’m interested’ in order to contact the hiring manager.

Please refer the Job description for details