QA Manager ESO AI & Chemicals - Release (m/f/d) " >QA Manager ESO AI & Chemicals - Release (m/f/d)

Oct 26, 2021

Job Description

9 years in a row! Lek is among the most reputable employers in Slovenia.

Your role as QA Manager ESO AI & Chemicals - release (m/f/d) is support in approving and maintaining quality oversight and release with respect to supply of Drug substances and Medical devices to Novartis, from external suppliers.

Your key responsibilities:
• Responsible for Drug substance (DS) and Medical device (MD) batch disposition (release) supplied from 3rd party suppliers.
• Ensures that supplies batches of DS and MD are in compliance with registration requirements, GMP standards and Novartis internal standards.
• Ensures that the batch relevant records have been reviewed for accuracy, completeness and compliance with relevant standard operating procedures in accordance with GMP requirements.
• Ensures that any issue identified during disposition activity is documented in line with the relevant procedures.
• Ensures that any restriction originating from deviations and/or change requests for example, are considered at final disposition.

Imagine what you could experience at Novartis and learn more at Novartis Teams and Skills I Novartis .

Diversity & Inclusion / EEO

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

Minimum Requirements

What you’ll bring to the role:
• University degree (MSc is desirable) in pharmaceutical, chemical or other related sciences.
• At least 5 years of experience in experiences in production, testing, release or/and QA Oversight of Drug substances and/or Medical devices.
• Excellent knowledge of English language (written and spoken).
• Flexibility to work in a fast paced, constantly evolving work environment.
• Ability to operate in a global matrix environment.

Desirable Requirements:
• Preferably experiences with Active Pharmaceutical Ingredients (API).

You’ll receive

Flexible working schedule, competitive compensation package, annual bonus, possibility to work from home, pension scheme, employee recognition scheme, sports club membership, employment at Top SI employer, learning and development opportunities and much more.

Possible job locations: Slovenia (Ljubljana, Mengeš, Lendava, Prevalje)

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

You are kindly invited to submit your application in Slovene and English language, including CV on our website by 5th of November 2021.

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!

Novartis are an equal opportunities employer and welcome applications from all suitably qualified persons.

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:
Novartis Technical Operations
Full Time
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QA Manager ESO AI & Chemicals - Release (m/f/d)

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