GMP Officer (m/f/d)

Job Description

Location: Schaftenau, Austria

Role Purpose:
35! You will be part of a team of 35 people developing Biosimilars and new Biologic drugs. Our team is responsible to release the products for clinical trials and defining the shelf life of the product. You as a GMP Officer (m/f/d) will be supportive to keep the processes within Biologics Analytical Operations up to date and that they meet the current GMP guidelines.

Your Responsibilities:
• Responsible for the preparation of and participation in internal and external inspections covering GMP
• Act as single point of contact for self-Inspections and coordinate follow-up activities
• Assure in collaboration with Quality Assurance and Analytical Experts that our laboratories keep a high-quality standard
• Perform Pharmacopoeia assessments and track implementation of new or revised guidelines within the lab
• Lead and manage project and network activities, support/coach team members and contribute to overall compliance strategy.
• Coordinate and supervise QA initiatives as SPOC for the analytical laboratories.

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:
• Technical expert studies with PhD and 5 years relevant experience or Master of Science with 7 years of relevant experience or Bachelor of Science or equivalent technical education with 10 years relevant experience in industry or equivalent
• 2 years’ experience within quality control or quality assurance
• Fluency in English, German beneficial
• Excellent knowledge of qualification processes for laboratory systems in a GMP environment including software qualification (CSV) and related technical tools and software.
• Adequate knowledge of software and computer tools (e.g. Chromeleon)
• Strong scientific project management (preferable LEAN six sigma) and leadership skills
• Excellent knowledge on relevant regulatory, guidelines and good understanding of regulatory expectations.
• Experience within external Audits (e.g. FDA, EMA)

Desirable requirements:
• A personality with a can-do mind-set and the ability to adapt to change with strong communication and presentation skills
• Excellent problem solving mind-set, attitude to resolve challenges, interdisciplinary thinking
• Excellent organizational skills, team player, flexible and dedicated personality

Adjustments for Applicants with Disabilities:
If because of a medical condition, physical disability or a neuro diverse condition you require an adjustment during the recruitment process, please reach out to [email protected] and let us know the nature of your request as well as your contact information. The support which we can provide will include advice on suitable position as well as guidance at all stages of the application process. Austrian law provides candidates the opportunity to involve the local disability representative, Behindertenvertrauensperson (BVP), in the application process. If you would like to request this, please let us know in advance as a note on your CV.

Why Novartis?
236 million lives were touched by Novartis medicines in 2022, 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 ₠60,212.18/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.
We are open for part-time and job sharing models and support flexible and remote working where possible