About the role

Aplyr's Quick Take

This role is focused on managing quality assurance and compliance in a pharmaceutical setting. You'll be involved in ensuring GxP conformity, handling technical complaints, and supporting continuous improvement projects. It's primarily an individual contributor role with some collaboration across teams.

Good fit

Ideal candidates will have experience in quality assurance or control within the pharmaceutical or biotech industries, particularly with GxP standards. Strong problem-solving skills and the ability to navigate ambiguity are essential.

Worth noting

The role emphasizes quick reporting of technical complaints and compliance with strict regulatory standards, which may indicate a high-pressure environment. There's a clear focus on continuous improvement, suggesting opportunities for professional growth.

Job Description Summary

-Manages Quality aspects and projects within area of responsibility.
-Ensures and supports overall GxP conformity and Compliance with the Novartis Quality Management Systems.

Job Description

Major Accountabilities:

QC/ QA in pharmaceutical ind./ biotech with environmental monitoring & cleanliness zones, Functional Breadth, Collaborating across boundaries
Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt
Distribution of marketing samples (where applicable)

Key Performance Indicators:

On-time and GMP-compliant release of dosage forms
No complaints about inspections by authorities in your own area of responsibility without these being noticed & communicated beforehand
Successfully support continuous improvement projects
Executes batch release in compliance with registration

Work Experience:

Quality Assurance
Quality Control
Quality Management Systems
Technological Expertise
Environmental Monitoring
Release Management
Good Manufacturing Practices (cGMP)
Audit & Inspection Management
Quality Compliance
Technological Expertise

Skills:

Collaboration
Dealing With Ambiguity
Operational Excellence
Regulatory requirements knowledge
Problem Solving Skills
Leadership
Communication skills
Data Integrity
Digital saviness

Languages:

English.

Skills Desired

Collaboration, Communication Skills, Data Integrity, Dealing With Ambiguity, Digital saviness, Leadership, Operational Excellence, Problem Solving Skills, Regulatory Requirements knowledge

Aplyr's read

Novartis is a Swiss-based global healthcare leader, known for its focus on innovative medicines and commitment to addressing patient needs through diverse roles.
Synthesized from recent postings & public sources

What's promising

•Novartis invests heavily in research and development, driving innovation in pharmaceuticals.
•The company offers a wide range of global career opportunities across various fields.
•Strong focus on cutting-edge therapies, including gene therapy and AI-driven solutions.

What to watch

•Regulatory challenges can impact the speed of drug approval and market entry.
•High competition in the pharmaceutical industry requires constant innovation to maintain market position.
•Complex organizational structure may slow decision-making processes.

Why Novartis

•Novartis has a robust pipeline of innovative medicines, setting it apart in the healthcare sector.
•The company emphasizes a diverse and inclusive workplace culture across its global operations.
•Novartis is a leader in digital transformation within pharmaceuticals, integrating AI and data science.

Aplyr’s read is generated by AI from public sources. Was it useful?

About Novartis

Novartis

novartis.com

View company

Novartis is a global healthcare company based in Switzerland that provides solutions to address the evolving needs of patients worldwide. It focuses on innovative medicines, generics, and eye care.