QA Compliance Postgraduate - German Speaker

WillHire; Stein; Vor Ort; CHF 110.000 - 140.000; Vollzeit

Zusammenfassung

Novartis is seeking a postgraduate QA Compliance professional to support inspection management, compliance activities, and implementation of the Novartis Quality Management System at the Stein site in Switzerland.

You will help ensure site- and product-related activities meet cGxP, data integrity, and international regulatory requirements while collaborating with Manufacturing and Quality Management teams to drive continuous improvement.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

GMP knowledge

Regulatory guidelines

Communication skills

Organizational skills

GMP auditing understanding

English & German proficiency

Ausbildung

Science degree (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.

Responsibilities

• 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

What you’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.