Senior Quality Assurance Operations Specialist at Novartis

Kundl, Tyrol, Austria -

Full Time

Start Date

Immediate

Expiry Date

29 Aug, 26

Salary

0.0

Posted On

31 May, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Collaboration, Communication Skills, Data Integrity, Dealing With Ambiguity, Digital Savviness, Leadership, Operational Excellence, Problem Solving Skills, Regulatory Requirements Knowledge, GMP Compliance, Batch Record Review, CAPA Management

Industry

Pharmaceutical Manufacturing

Description

Band Level 3 Job Description Summary The Senior QA Operations Specialist is responsible for providing quality assurance support for drug substance manufacturing activities, with a strong focus on batch record review and GMP compliance. The role ensures timely and compliant batch release, supports investigations and audits, and contributes to maintaining the Novartis Quality Management System. Job Description This position is a temporary, activity‑based role and is limited to a fixed term of two years. Key Responsibilities Review and approval of batch manufacturing records as part of the batch release process Review and assessment of analytical results, certificates, and specifications Control and verification of batch documentation and quality records Support audits, inspections, and regulatory interactions, investigations related to deviations, OOS/OOE, and complaints Support CAPA management activities and changes to processes, documentation, and quality requirements Preparation and review of certificates, reports, and quality-related lists Communication and coordination with internal departments and external partners Execution of tasks in a timely, efficient, and GMP‑compliant manner Obligatory requirements: Solid experience in a pharmaceutical or GMP‑regulated environment. Experience in Quality Assurance or quality control is preferred. Strong knowledge of GMP requirements. Results‑driven mindset with continuous improvement focus Strong customer focus and communication skills Fluent in German, basic English 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 € 59.781,96/year (on a full-time basis). We also offer a potential market oriented excess payment in line with your experience and qualifications. 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 Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally. Read our handbook (PDF 30 MB) Skills Desired Collaboration, Communication Skills, Data Integrity, Dealing With Ambiguity, Digital saviness, Leadership, Operational Excellence, Problem Solving Skills, Regulatory Requirements knowledge Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people’s lives. Novartis is aware of employment scams which make false use of our company name or leader’s names or recruiter’s names to defraud job seekers. Novartis does not make job offers without interview and never asks candidates for money. If you have encountered a job posting or been approached with a job offer that you suspect may be fraudulent, we strongly recommend you do not respond, send money or personal information. In the context of China Cross-Border Data Transfer (CBDT) policy, if you need to apply for a position in China, please go to the local Recruiting System TaleNov .

Responsibilities

Responsible for quality assurance support in drug substance manufacturing, focusing on batch record review and GMP compliance. The role ensures timely batch release and supports investigations, audits, and the Quality Management System.