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R&D Quality Specialist Vacancy
Location: Basel, Switzerland
Sector: Pharma
Start: 06/2025
Duration: 19+ months
Workload: 100%
Ref. No.: BH 22927
Job Description
We are seeking an R&D Quality Specialist for a globally operating Basel-based pharmaceutical company. The role involves:
1. Performing, supporting, or supervising instrument qualification activities and change control, including documentation review and LU approval.
2. Managing instrument life-cycle activities such as calibration and re-qualification.
3. Acting as the liaison between local QA, ARD, and service providers regarding instrument processes, and representing global ARD in networks and committees.
4. Supporting the establishment and maintenance of a GMP management system for analytical instruments.
5. Maintaining the instrument database within the GMP system.
6. Overseeing GMP instrument activities and coordinating updates to the validation master plan.
7. Serving as the first contact point for general inquiries between QA and ARD.
8. Representing global ARD in instrument-related initiatives.
9. Advising staff on instrument issues and deviations.
10. Supporting training programs and ensuring proper training.
11. Writing and reviewing qualification documents and guidelines.
12. Assisting with updates to re-qualification and calibration documents.
13. Comparing calibration results with SOP requirements.
14. Supporting audits, inspections, and laboratory walk-throughs.
15. Managing deviations related to analytical instruments in compliance with standards.
16. Authoring procedures for instrument and system management.
Qualifications and Experience
* 5-6 years of professional experience in a related field.
* Master's degree.
* Experience in analysis, QA, instrument management, or qualification.
* Strong communication skills, flexibility, eagerness to learn, and accountability.
* Fluency in English.
Additional Information
Applicants should send their resume with a contact number. Due to Swiss work permit restrictions, applications from Swiss nationals, EU citizens, and current Swiss work permit holders are considered. Ukrainian refugees are warmly welcomed and supported. We value diversity and encourage applications from all backgrounds.
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