Main Responsibilities:
•Performs, supports or supervises instrument related qualification activities and change control including issuing, review and LU approval of corresponding documentation. Responsible for instrument life-cycle activities like calibration and re-qualification.
•Serves as the point of contact between local QA and local ARD and service provider (if applicable) for inquiries regarding instrument related processes and represents global ARD in related networks, committees, and initiatives, if necessary, and collaborates with Qualification Experts and similar roles within global TRD.
•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 re-qualification 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 the company and regulatory standards. Author of procedures for instrument and system management.
Qualifications and Experience:
•Relevant working/residency permit or Swiss/EU-Citizenship required
•Master degree or equivalent
•5-6 years’ experience: Analyst experience / QA experience / Instrument management experience / Instrument Qualification experience
•Fluent in German, English required
•Good communication skills, flexibility for a dynamic environment, eager to learn and grow in different area, accountability