Quality Specialist

Job Description

12,000! That’s the number of our Global Drug Development (GDD) associates we empower to deliver value to patients through our development of products and programs that create knowledge, deliver learning and build applied skills. We have high ambitions to transform the way we help people learn, and we’re building a Capability team who have the imagination, grit and expertise to make that a reality, fast.

Your key responsibilities:
Your responsibilities include, but not limited to:

• Support the timely release of GMP relevant documents and batches. Support departmental projects and objectives according to agreed timelines and standards in the given area of competency and support adherence to compliance with cGMP in TRD.
• Support a discipline and/or provide a service individually or within a team of associates. May provide functional expertise to Line Unit and other QA Units in area of responsibility.
• Write and review GMP-relevant deliverables and or/ related tools as per area of responsibility in order to ensure compliance with cGMP and project quality deliverables.
• Support project related activities (e.g. TRD product portfolio, development of new tools, processes, Quality initiatives, Quality Manual implementation, Quality Plans, Quality Risk Assessments, training activities, qualification and facility upgrade activities, IT validation projects) as per area of responsibility.
• Comply with internal and external guidelines regarding quality and safety (Quality Manual, regulatory cGMP guidelines, Health Authority guidances, SOPs etc.)
• Approval of GMP relevant documents (as specified below) and decision making according to applicable processes. Review and Approval of executed analytical batch documentation records including attachments. Review and Approval of Analytical specifications (GLIMS)
• Manages projects and processes to support departmental portfolio, projects and objectives according to agreed timelines and standards

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

What you’ll bring to the role:

• Minimum: Degree in Science, laboratory, manufacturing or relevant discipline.
• Relevant working experience of 8+ years in Analytical R&D, QC or QA. 8+ years’ experience in review of GxP documents in analytical R&D, quality control along quality assurance experience
• Well verse with different analytical techniques such as HPLC, Chromatography, wet analysis, Water by KF, Spectroscopy.
• Scientific, technical, and regulatory knowledge in a specific area. Basic knowledge of drug development.
• Communication skills to address GMP and logistic related questions with the line unit experts.
• Detailed knowledge of cGMP, working knowledge of safety and environmental regulations and guidelines.
• Ability to analyze and evaluate GMP compliance. Detail-oriented individual. Knowledge and flexibility to work with relevant IT systems.

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!

Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

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