Join to apply for the R&D Quality Specialist role at RM Group (Switzerland)
Get AI-powered advice on this job and more exclusive features.
R&D Quality Specialist vacancy for a globally operating Basel-based company in the Pharma sector.
Your tasks:
* Perform, support, or supervise instrument-related qualification activities and change control, including issuing, reviewing, and LU approval of documentation.
* Manage instrument lifecycle activities such as calibration and re-qualification.
* Serve as the contact point between local QA, local ARD, and service providers for instrument-related inquiries, representing global ARD in networks, committees, and initiatives, collaborating with Qualification Experts within global TRD.
* Support the establishment and maintenance of a GMP management system for analytical instruments at ARD.
* Maintain the instrument database within the GMP management system for analytical instruments in ARD.
* Oversee GMP instrument activities within local ARD and coordinate annual updates of the validation master plan.
* Act as the first contact between local QA and ARD for general inquiries.
* Represent global ARD in analytical instrument initiatives as appropriate.
* Provide advice and assistance to staff on instrument-related issues and deviations.
* Support training programs for employees and contractors, ensuring adequate training.
* Write and review qualification documents and guidelines related to instruments.
* Contribute to updates of re-qualification and calibration documents and guidelines.
* Compare external calibration results with specific instrument requirements as per SOP.
* Assist in audits, inspections, and laboratory walk-throughs, including preparation and follow-up.
* Manage deviations related to analytical instruments in compliance with standards.
* Author procedures for instrument and system management.
Your experience/knowledge:
* 5-6 years of professional experience in a similar field.
* Experience as an analyst, in QA, instrument management, or instrument qualification.
* Good communication skills, flexibility, eagerness to learn, accountability.
* Fluency in English.
Location: Basel, Switzerland
Work setting: Hybrid
Sector: Pharma
Start: 06/2025
Duration: 19+ months
Workload: 100%
Ref.Nr.: BH 22927
Take the next step by sending your resume and a daytime phone number.
Seniority level
* Entry level
Employment type
* Full-time
Job function
* Research
Industries
* Pharmaceutical Manufacturing
#J-18808-Ljbffr