Country Quality Support (m/f/d), 100%

• Supports establishing and maintenance of a GMP management system for analytical instruments at ARD. Responsible for maintaining the instrument database in GMP management system for analytical instruments in ARD.
• Oversees the GMP instrument activities within local ARD and coordinates the annual update of the validation master plan when required. Serves as the first point of contact between local QA and local ARD for general inquiries.
• Represents global ARD in analytical instrument related initiatives as appropriate. Provides advice and assistance to staff on analytical instrument related problems and deviations.
• Supports employee and contractor training programs in coordination with other roles and ensures that sufficient and appropriate training is provided.
• Writes and reviews instrument-related qualification documents and guidelines. Writes, reviews or provides input during the update of instrument-related requalification and calibration documents and guidelines.
• Compares externally determined calibration results with the specific requirements for the instrument to be applied, if required by the instrument use SOP. Supports audits, inspections and laboratory walk-throughs in terms of preparation, conducting and following up.
• Experienced in managing deviations related to analytical instruments in compliance with regulatory standards. Author of procedures for instrument and system management.

• Analyst experience
• QA experience
• Instrument management experience
• Instrument Qualification experience
• Master degree (university)
• good communication skills, flexibility for a dynamic environment, eager to learn and grow in different area, accountability
• Languages: Fluent in English, German as a plus

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