QA Compliance Postgraduate - German Speaker

Novartis; Stein; Vor Ort; CHF 80.000 - 100.000; Vollzeit

Zusammenfassung

Novartis in Stein, Switzerland, is seeking a postgraduate for the QA Compliance department. You will provide expert support in inspection management and compliance, ensuring that activities comply with cGxP requirements and internal quality standards.

The ideal candidate has a degree in a scientific discipline, knowledge of GMP guidelines, and strong communication skills. This role offers a unique opportunity to contribute to quality initiatives in a globally impactful environment.

Qualifikationen

• University degree in a relevant scientific discipline.
• Basic knowledge of GMP requirements and regulatory guidelines.
• Initial experience in pharmaceutical manufacturing or QA/QC is beneficial.

Aufgaben

• Support the preparation and coordination of Annual Product Quality Review activities.
• Contribute to the implementation and improvement of Quality Systems.
• Participate in on-site health authority inspections.

Kenntnisse

Strong communication skills

Good organizational skills

Basic knowledge of current GMP requirements

Proficiency in English and German

Ausbildung

University degree or postgraduate qualification in Chemistry, Pharmacy, Microbiology, Biotechnology

Jobbeschreibung

With more than 30 different sterile products supplied to over 120 countries, our site operates in a highly regulated and globally impactful environment. As a postgraduate in the QA Compliance department, you will provide expert support in inspection management, compliance activities, and the implementation of the Novartis Quality Management System. In this role, you will help ensure that all site- and product-related activities comply with cGxP requirements, including data integrity principles, Novartis internal quality standards, and applicable international and local regulatory requirements.

Your responsibilities include but are not limited to:

• Supports the preparation and coordination of Annual Product Quality Review activities in accordance with Novartis procedures.
• Supports third‑party management activities and related compliance processes.
• Contributes to the implementation and continuous improvement of Quality Systems.
• Participates in on‑site health authority inspections and customer audits.
• Supports continuous improvement initiatives within the QA Compliance department.
• Supports CAPA tracking as well as the preparation, reporting, and review of QA department metrics, including Monthly Quality Reports and KPI reports.
• Collaborates with cross‑functional teams across Manufacturing and Quality Management.
• Ensures that all assigned activities and projects are performed in compliance with cGxP requirements, including data integrity principles.

Minimum Requirements

Whatyou’ll bring to the role:

• University degree or postgraduate qualification in Chemistry, Pharmacy, Microbiology, Biotechnology, or a related scientific discipline.
• Basic knowledge of current GMP requirements and relevant regulatory guidelines, such as ICH, FDA, and EMA expectations.
• Initial experience in a pharmaceutical manufacturing environment and/or in QA/QC is beneficial.
• Strong communication skills, with the ability to collaborate effectively across functions.
• Good organizational skills, including effective time and self‑management.
• Basic understanding of GMP auditing processes is an advantage.
• Proficiency in English and German, both written and spoken.

Commitment to Diversity & Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.