Country Quality Support

Proclinical Staffing; Basel; Vor Ort; CHF 80’000 - 100’000; Vollzeit

Zusammenfassung

A leading life sciences recruiter is seeking a Country Quality Support professional in Basel to ensure top-tier quality standards through managing analytical instruments and overseeing compliance in a GMP-regulated environment. The ideal candidate has strong experience in instrument qualification, excellent communication skills, and a keen eye for detail. This role offers a dynamic work environment with significant responsibilities in quality assurance.

Qualifikationen

• Strong experience in analytical instrument management, qualification, and calibration.
• Familiarity with GMP regulations and quality assurance processes.
• Proficiency in managing instrument databases and validation master plans.

Aufgaben

• Perform and supervise instrument qualification activities.
• Manage the lifecycle of analytical instruments.
• Act as primary contact for instrument-related inquiries.
• Establish and maintain a GMP management system.

Kenntnisse

Analytical instrument management

GMP regulations

Communication skills

Document writing

Jobbeschreibung

Are you passionate about quality and precision? Join our client as Country Quality Support and help ensure top-tier standards every day.

Proclinical is seeking a dedicated individual for Country Quality to support and oversee the qualification, calibration, and lifecycle management of analytical instruments within a GMP-regulated environment. This role involves collaboration with cross-functional teams, including Quality Assurance (QA) and Analytical Research & Development (ARD), to ensure compliance with regulatory standards and internal guidelines. You will play a key role in maintaining instrument databases, supporting audits, and contributing to training programs.

Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.

Responsibilities:

• Perform and supervise instrument qualification activities, including documentation review and approval.
• Manage the lifecycle of analytical instruments, including calibration and re-qualification processes.
• Act as the primary contact between local QA, ARD, and service providers for instrument-related inquiries.
• Represent global ARD in networks, committees, and initiatives related to analytical instruments.
• Establish and maintain a GMP management system for analytical instruments.
• Maintain and update the instrument database within the GMP management system.
• Oversee GMP instrument activities and coordinate updates to the validation master plan.
• Provide guidance on instrument-related problems, deviations, and compliance issues.
• Support employee and contractor training programs related to analytical instruments.
• Write, review, and update qualification, calibration, and re-qualification documents and guidelines.
• Compare calibration results with specific instrument requirements as needed.
• Assist in audit preparation, execution, and follow-up activities.
• Manage deviations related to analytical instruments in compliance with regulatory standards.

Key Skills and Requirements:

• Strong experience in analytical instrument management, qualification, and calibration.
• Familiarity with GMP regulations and quality assurance processes.
• Proficiency in managing instrument databases and validation master plans.
• Excellent communication skills and ability to collaborate across teams.
• Flexibility to adapt to a dynamic work environment and eagerness to learn.
• Accountability and attention to detail in managing compliance-related tasks.
• Experience in writing and reviewing technical documents and procedures.
• Ability to support audits and inspections effectively.
  

If you are having difficulty in applying or if you have any questions, please contact Ashley Bennett at [e-mail].

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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