343677BR
Apr 26, 2022
Slovenia

Job Description

28,000 associates of more than 100 nationalities deliver high quality and affordable medicine on time, every time, safely and efficiently.

The QA eCompliance Expert is responsible for the compliance and Quality Assurance support of the GxP production computerized systems including supplier quality assessment/management throughout their lifecycles in regards to the applicable regulations and requirements defined in the Novartis Quality Manual and procedures.

Your key responsibilities:
• Ensure implementation of the applicable Novartis and regulatory requirements for GxP regulated computerized systems. Provide quality assurance expertise / guidance for GxP computerized systems qualification, supplier assessment, change control, deviation management and associates activities that ensure compliance to regulatory and company expectations.
• Review and approve determination of production equipment/systems for GxP applicability.
• Maintain close relationship with the applicable Regional eCompliance Manager(s) and perform timely support for projects, inspections and audits.
• Perform life-cycle activities of the GxP equipment/systems in scope (e.g.: periodic reviews, change controls, deviations management, risk mitigations) including review & approval of relevant documentation and its maintenance according to the Novartis requirements.
• Provide guidance and support on the development of business processes around in scope GxP production computerized equipment/systems.
• Supports QA and eCompliance strategic activities as assigned.

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 engineering, computer science, life sciences.
• Fluency in English (oral and written), very good knowledge of German.
• At least 5 years of overall automation/CSV experience, and of Process Automation Systems in the Pharmaceutical Industry or another regulated industry.

You’ll receive

Competitive salary, Annual bonus, Flexible working schedule, tailored to your needs, possibility to work from home, Pension scheme, Employee Recognition Scheme, Sports Club Membership, employment at Top SI Employer, Learning and development opportunities.

We offer permanent employment, with 6 months of probation period.

You are kindly invited to submit your application in English language, including CV by 10th of May 2022.

Why Novartis?

769 million lives were touched by Novartis medicines in 2020, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives.

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 do here at Novartis!

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.

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 Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

Novartis Technical Operations
NTO QUALITY
Slovenia
Ljubljana
Quality
Full Time
Regular
No
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343677BR

QA eCompliance Expert (m/f/d)

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