QA Operations Expert (f/m/d)

Job Description

QA Compliance Expert (w/m/d) - Change Management, Novartis Technical Operations, Kundl/Schaftenau, Austria

1886! We have more than 130 years of experience in the industry. Sandoz is a global leader in the field of generics and biosimilars.

Your Responsibilities:
• Implementation of GMP requirements within CQF QC department as QA for QC
• Ensuring compliance in line with GxP regulations and company requirements throughout the Life Cycle of equipments / systems and clean rooms in laboratory & sampling area
• Performance of QA reviews and approvals for documentation in qualification, monitoring, risk assessments, investigation reports and related activities (changes etc)
• Assistance and approval of periodic compliance reviews and monitoring of risk mitigation activities
- QA contact person and contact partner for business functions
• Participation in site-wide GxP working groups, Self-Inspections & preparation for inspections/audits (e.g. support of response to observations and requests)
• Creation and maintenance of area-specific SOPs and optimization of established procedures
• Conducting GxP training

Diversity & Inclusion / EEO

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

Minimum Requirements

Your Profile:
• University degree in Engineering, Pharmacy, Biochemistry, Biotechnology, Chemistry, Microbiology or equivalent
• At least 3 years or more experience in QC or QA or medical device industry
• Experience in operations management and execution
• Preferably experience in negotiations and global collaboration
• Fluent knowledge of English language (written and spoken), German is an advantage
• Flexibility to work in a fast paced, quickly changing work environment
• Ability to operate in a global matrix environment

Why Novartis?

766 million lives were touched by Novartis medicines in 2021, 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!

In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development options as well as worldwide career opportunities 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 € 54,788.3 /year (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.

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.
Our recruitment decisions are based on selecting the best person for the job, regardless of gender, religion, age, colour, race, sexual orientation, nationality or disability.

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