Mar 17, 2023

Job Description

2023 will see Sandoz become a standalone organization! As a global market leader in Generics and Biosimilar medicine, Sandoz is stepping forward from a position of strength! Those joining Sandoz in the coming months will help shape the future of the company, it’s growth, innovation, culture and how Sandoz impacts the lives of millions. These will be careers with genuine impact! This is one such role!

Are you ready to make a difference?

As a QA eCompliance Specialist (m/f/d) you will be responsible for the compliance and Quality Assurance support of the GxP computerized systems including supplier quality assessment/management throughout their lifecycles in regard to the applicable regulations and requirements defined in the Novartis Quality Manual and procedures. eCompliance provides guidance on CSV-related topics and related information. Reviews and/or approves the qualification and operational deliverables of respective GxP computerized systems. Managing work in accordance with the law, internal regulations, good practices and business objectives.

Your key responsibilities:
• Support site qualification and validation activities (planning, advising, review).
• Audit and inspection preparation and support.
• Change control review/approval.
• Ensure process quality assurance acc. to regulations.
• Ensure implementation of the applicable Novartis and regulatory requirements for GxP-regulated computerized systems.
• Provide quality assurance expertise / guidance for GxP computerized systems classification, qualification, supplier assessment, change control, deviation management and associated activities that ensure compliance to regulatory and company expectations.
• Review and approve the determination of the computerized system for GxP applicability.
• Adopts & develops new capabilities in alignment with Business needs.

Diversity & Inclusion / EEO

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

Minimum Requirements

What you will bring to the role:
• Degree in chemistry, biology, computer science, life sciences.
• Minimum 3 years of overall automation/CSV experience, or a minimum of 3 years of Laboratory.
• Functional knowledge of English.
• Knowledge of Microsoft Office.


We offer permanent employment, with a 6-month probation period.

You are kindly invited to submit your application in the English language, including CV by the 31st of March 2023.

Why Sandoz?
500 million patients were touched by Sandoz generic and biosimilar medicines in 2021 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.

How will we do this? We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could achieve here at Sandoz!

Commitment to Diversity & Inclusion
Sandoz is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Join our Sandoz Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here: https://talentnetwork.novartis.com/sandoztalentpool
Novartis Technical Operations
Full Time
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QA eCompliance Specialist (m/f/d)

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