QA Compliance Expert (m/f/d)

Jul 09, 2021

Job Description

QA Compliance Manufacturing Expert (m/f/d)

QA Compliance Manufacturing Expert (m/f/d), Quality Large Molecules, Drug Substance Schaftenau, Austria

>1 Tone! This the amount of API (active pharmaceutical ingredient) which is produced per year in the site Drug Substance Schaftenau. The team is responsible for handling all compliance topics for our commercial projects. In the role as a QA Compliance Manufacturing Expert (f/m/d), you will be part of the Adventitious Agents Team actively contributing towards ensuring patient safety and supporting the supply of our medicine to the patients worldwide.

Your key responsibilities:

Your responsibilities include, but are not limited to:
• Ensure GMP Compliance in the GMP facilities of NTO DS Bioproduction Schaftenau (DSS); specifically: support the set up of a new QC laboratory. Act as QA in design, qualification and release phases of laboratory building and infrastructure systems.
• Cooperation with the engineering department for planning of new labs to ensure GMP compliance (e.g.: planning of room concept, DIOPQ of utilities; HVAC and automation, etc.)
• Ensure change management for plants/ rooms/ equipment/ automation system/ HVAC and utilities for the project and interfaces (site infrastructure)
• Approval of lab specific qualification documents (plans and reports, risk assessments, etc.)
• Support of health authority inspections and internal audits
• Ensure GMP standards in cooperation with external service providers (engineering companies)
• Review and approval of SOP as QA related to QC laboratory
• Act as QA in deviation handling within the project

Minimum Requirements

What you’ll bring to the role:
• University degree or higher education with long experience in GMP environment
• Fluent both, English and German language
• Min. 3 years working experience in GMP-area (i.e. production, QA, engineering or development)
• Being able to take over responsibility for own task, reliability
• Good Cooperation with engineering and production and within QA Compliance DSS
• Oriented to costumer
• Quality focus: Wanting to deliver high quality work and expecting such work from others
• Respect and open for feedback; friendly
• Innovation and creativity: Oriented to problem solving and improvement

Desirable requirements:
• Calm and stress resistant. Openness to teamwork

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 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 € 51.180/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, color, 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:
Novartis Technical Operations
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QA Compliance Expert (m/f/d)

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