QA Compliance Postgraduate

Job Description Summary

30+ different sterile products, 120+ countries supplied with our products! As a postgraduate in the QA Compliance department, you provide expert support in the areas of inspection management, compliance and implementation of the Novartis Quality Management System to ensure all activities related to both site and product are compliant with cGxP requirements (incl. data integrity), Novartis internal quality standards, and relevant international and local regulatory requirements. We are looking forward to your application!
Start date: As soon as possible
Duration: 1 year
Languages: business-level English and fluent German required

Job Description

Your responsibilities will include:

• Ensure all activities are in compliance with cGxP, incl. data integrity

• Support with the preparation of Annual Product Quality Review activities according to Novartis procedure

• Support with Third Party management activities

• Support with the implementation of Quality Systems

• Participate in on-site Health Authority inspections and customer audits

• Support with continuous improvement projects within the QA compliance department

• Support with CAPA tracking and assisting, reporting and reviewing of QA department metrics e.g. Monthly quality report, KPI reports.

• Collaborate with cross-functional teams within manufacturing and Quality Management.

What you’ll bring to the role: 

• Recent BSc or MSc graduate in Chemistry, Pharmacy, Microbiology, Biotechnology or related science (degree completed within the past ca. 12 months)

• Knowledge of current GMP and Regulatory guidelines (ICH, FDA, EMA)

• Experience in pharmaceutical manufacturing site and/or QA/QC is beneficial

• Strong communication and negotiation skills, excellent time and self-management

• Knowledge of GMP Auditing processes preferable

• Proficient English (spoken & written) and fluent German (spoken & written)

Please submit a cover letter that includes your motivation for the position and from when you will be available. Thank you.

Why Novartis

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?

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.

Accessibility and accommodation:

Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to diversity.inclusion_ch@novartis.com, and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

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Skills Desired

Summary

• Location: Stein Aargau
• Type: Full time