QA Operations Expert

Summary

#LiHybrid

Location: Schaftenau.

As part of our team, you will be supporting introduction of new autoinjector devices to commercial phase and manage the primary packaging and/or device suppliers from a quality point of view.

You will be responsible for managing quality aspects within area of responsibility and to ensure that the operational business is in compliance with cGMP, the Quality Assurance Agreements, regulatory requirements, the Novartis Quality Manual and is conducted according to the relevant Standard Operating Procedures.

Major accountabilities

• Responsible for third party management of device component and primary packaging material suppliers.
• Responsible for evaluation and implementation of changes related to assigned materials.
• Oversight of incoming testing activities, ensuring compliance with cGxP, including data integrity and eCompliance.
• Review and approve production, QC, and AS&T records.
• Support exception investigations.
• Review and approval of DHF and DMR documents for Commercial medical devices and combination products.
• Reporting of technical complaints, adverse events and special case scenarios related to Novartis products within 24 hours of receipt.
• Support OpEx improvement projects.

Essential Requirements

• University degree in Engineering, Pharmacy, Biochemistry, Biotechnology, Chemistry, Microbiology or equivalent.
• At least 3 years or more experience in MS&T, QC, QA or medical device industry.
• Experience in relevant operations or third party management.
• Fluent knowledge of English language, written and spoken.
• Flexibility to work in a fast paced, quickly changing work environment.

Desirable requirements

• Experience in negotiations and global collaboration.
• Fluent in German.

Rewards

You can find everything you need to know about benefits and rewards in the Novartis Life Handbook: https://www.novartis.com/careers/benefits-rewards

In addition to a market-competitive base salary, Novartis offers 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.

For this position the primary location salary range is €66,918.00 - €105,200.00 per year. In accordance with Austrian law, the minimum salary stated in the collective bargaining agreement is €65,605.54 per year on a full time basis. A potential market oriented excess payment may be offered in line with experience and qualifications.

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