Analyst Quality Control

Role

Full-time

Permanent

Mid

Logistics

Schaffhausen, Switzerland

On-site

Requirements

Bachelor's

EU/EFTA permit

Languages

German C1

English C1

Description

Als QC Lab Systems Specialist sind Sie Teil der Abteilung QC Lab Services innerhalb der Quality Control Organisation in Schaffhausen. Sie sind verantwortlich für die Planung und Durchführung der periodischen Überprüfung der Analytischen Instrumentenqualifizierung (AIQ). Mit dieser Tätigkeit stellen Sie sicher, dass der qualifizierte Zustand computergestützter Laborgeräte während ihres gesamten Lebenszyklus, von der Erstqualifizierung bis zur Ausserbetriebnahme, erhalten bleibt und regulatorische Anforderungen erfüllt werden.

Responsibilities

Planning, coordination, and timely execution of AIQ Periodic Reviews.
Assessment of changes and deviations regarding their impact on the qualified state of laboratory equipment.
Documentation of results in device-specific reports.
Support the introduction of the new global HELPr tool.
Presentation of the AIQ-Periodic-Review process during regulatory inspections.
Creation and maintenance of standard operating procedures.
Conducting system audit trail reviews and user access reviews.
Collaboration in the creation and processing of deviations and change requests.

Requirements

Successfully completed studies in a scientific or technical field, preferably with a focus on pharmacy, chemistry, or biotechnology.
Strong organizational and communication skills.
Very good knowledge of Microsoft Office applications.
Experience in reviewing analytical data and GMP documents.
Knowledge of SAP and Comet is an advantage.
Very good German and English skills.
Interest in the development and automation of AIQ-Periodic-Review processes.
Ability to collaborate across departments.

Tech stack

Microsoft OfficeSAPComet

Benefits

Inclusive work environment.
Opportunities for professional development.
Support throughout the hiring process.

Company

Johnson & Johnson / Janssen

Pharmaceuticals

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.