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QA Operations Expert (m/f/d)

About the Role

Location: Austria, Tyrol, Schaftenau #LI-Hybrid

We We are seeking a QA Operations Expert (m/f/d) to help us with the implementation of quality assurance tasks such us release process of compounding / filling / inspection / packaging products and further development of the existing quality system.

This role will work directly with the QA Operations Team and reports to the QA Operations Team Leader.

Key Responsibilities:

• Ensuring GMP Compliance in Production.
• Participation in the preparation and approval of validations (e.g. process, mediafills, smoke studies), transfers and SOPs
• Approval of specifications, sampling instructions, test methods and other quality control procedures; as well as participation in and evaluation of changes in the process and specifications.
• Ensuring the evaluation of batch production and testing protocols.
• Timely decision on the use of intermediate and bulk products.
• Control and oversight of aseptic processes.
• Assisting in the preparation of QA agreements and answers to health authority questions, as well as preparation and participation in audits and inspections.
• Performance and approval of investigations of deviations and Out Of Specifications and Expectations (OOS and OOE), and support in complaint investigation, together with the evaluation and approval of CAPA measures and risk assessments.
• Alignment and improvement of existing processes and procedures to establish the Drug Production Schaftenau quality system.

Diversity & Inclusion / EEO

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

Role Requirements

Essential Requirements:

• University Degree in Pharmacy, Biochemistry, Biotechnology, Chemistry, Microbiology or equivalent.
• Professional experience in Pharmaceutical industry, Biopharmaceutical or API products.
• Excellent working knowledge and experience of pharmaceutical QA and cGMP standards.
• Proof of qualification and nomination as Control Laboratory Manager, Kontrollaborleiter/in (KLL), according to Regulation on Operating Instructions for Medicinal Products (AMBO).
• English & German proficiency.

Why Novartis?

Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

You'll receive:

You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development opportunities as well as worldwide career possibilities within the Novartis group. In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is € 60.212,18year (on a full-time basis). In most cases, the actual salary will be higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies.
We are open for part-time and job-sharing models and support flexible and remote working where possible.

Adjustments for Applicants with Disabilities:

If because of a medical condition, physical disability or a neurodiverse condition you require an adjustment during the recruitment process, please reach out to disabilities.austria@novartis.com and let us know the nature of your request as well as your contact information. The support which we can provide will include advice on suitable positions as well as guidance at all stages of the application process. Austrian law provides candidates the opportunity to involve the local disability representative, Behindertenvertrauensperson (BVP), in the application process. If you would like to request this, please let us know in advance as a note on your CV.

Join our Novartis Network:

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

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? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

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QA Operations Expert (m/f/d)


Veröffentlicht am 15.04.2024

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