346956BR
Jul 05, 2022
Slovenia

Job Description

With 53 manufacturing sites in 26 countries, our aspiration is to become the top manufacturer of innovative and generic medicines in the industry.

Wondering how innovative the QA department can be in developing large molecules? Join a team of 8 highly connected collaborators!

Your key responsibilities:
• Managing quality aspects of assigned TRD development projects, support and/or provide guidance on internal quality system in accordance with pharmaceutical regulations, good pharmaceutical practices and Novartis standards with minimal support.
• Accountable for quality oversight and associated decisions in Technical Development Operations.
• Accountable for third party management (establish QAA, oversee audit status and manage CAPA plan) with support of Senior QA Manager and Line function manager.
• Reviewing, deciding and approving on quality deliverables of technical development (e.g. batch record, SOP, third party approval, contractors).
• With training and specific delegation technical release of drug substance and drug product for clinical supply in accordance with the written specifications and local as well as international regulations.
• Collaborating across department and sites (e.g. Analytics, RegCMC, DP and DS Development) and exchanging knowledge.



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 will bring to the role:
• MSc in scientific or relevant discipline (e.g. pharmacy, biotechnology, chemistry, biology, physics, (chemical) engineering or related).
• English – fluent in reading, writing and oral skills. Site language - Basic understanding desirable.
• At least 2 years of experience in the field of development or production of DS or DP or relevant experience.

Desirable Requirements:
• Ability to negotiate, communicate internal and external.
• Good presentation skills.
• Good organizational / management skills.
• Sound scientific, technical or regulatory knowledge in a specific area.
• Good knowledge of cGMPs.

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 19th of July 2022.

Why Novartis?
More than 750 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.

Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

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
Global Drug Development
QA GDD
Slovenia
Menges
Quality
Full Time
Regular
No
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346956BR

QA Manager, Quality Technical Development (m/f/d)

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