Senior QA Operations Specialist (f/m/d)

Job Description

Senior QA Operations Specialist (f/m/d), Schaftenau/Tyrol, Austria

Your key responsibilities:
• Implement, comply with, and govern practices prescribed in the Novartis Manufacturing Manual
• Oversight of GxP functions across site and ensure product quality
• Ensure regulatory compliance and implementation of corporate quality standards and regulations
• Ensure status of local HA registration
• Ensure qualified state of facilities and utilities
• Support in the preparation of PQR / APQR
• Ensure exception (deviation and OOX) and complaint management and investigation
• Ensure proper definition and implementation of CAPA

Diversity & Inclusion / EEO

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

Minimum Requirements

What you'll bring to the role:
• University Degree in Pharmacy, Biochemistry, Biotechnology, Chemistry, Microbiology or finalized apprenticeship in an area of the Pharmaceutical industry
• Professional experience in Pharmaceutical industry, with direct experience with Pharmaceuticals, Biopharmaceutical or API products and ideally at least 2 years within QA, thorough knowledge of cGMP requirements as well as proven track record with FDA / EMA and other Health Authorities
• Being resilient
• Operational Excellence / NOSSCE
• Teamplayer

Why Novartis?

769 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!

In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning. 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 €54.735,38/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