Jun 08, 2022

Job Description

18 million Chinese patients benefit from Novartis products! ~25,000 associates of more than 100 nationalities; 50+ manufacturing sites network located in 25 countries; ~70 billion units supplied to more than 150 countries in 2019 covering 5 therapeutic areas. Over 30 years outstanding operations in Changping, Beijing. We deliver high quality, affordable medicines on time, every time, safely and efficiently. We strive to become the top manufacturer of innovative and generic medicines in the industry - while keeping our patients at the heart of everything we do.

Your responsibilities include, but are not limited to:
• Investigation (including deviation and compliant) handling. Manage and support deviation/compliant investigations within PU, Engineering and warehouse and other relevant areas. Support Quality Assurance and GQO with internal audit coordination, response, and follow-up activities.
• Be responsible for coordinating investigations and corrective actions with operating units, QA, Engineering, Contract Manufacturing Support, DRA, and suppliers to determine root causes and corrective actions to resolve complex, compliance related issues (e.g. product failures, stability failures, and compliance issues, including supplier investigations) and thus push the product quality improvements.
• Ensure the investigation handling procedures comply with the compliance requirement following the current HA regulations and company policies or procedures related to GMP and that there is a continuous drive to improve the compliance level;
• Review batch document and records timely, review QC testing record and confirm that QC report had been approved by QC coordinator that trained in appropriate disciplines and the product quality confirms to the specifications;
• The principal manufacturing and testing processes have been validated, if different;
• Any changes or deviations in manufacturing or quality control have been notified and evaluated in accordance with a well-defined system before any product is released
• Comply with all HSE guidelines
• Provide effective compliance supporting and services to others.

Diversity & Inclusion / EEO


Minimum Requirements

What you’ll bring to the role:
• Several years of experience in pharmaceutical quality control, quality assurance or production
• Operations Management and Execution; Functional Breadth; Collaborating across boundaries; Applied Practice
• University degree with a scientific / technological background (e.g. Chemistry, Pharmacy, Biology, Biochemistry, or equivalent)
• Qualified Person (depending on local requirements)

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!

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.

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, follow us via Novartis Group WeChat Recruitment Account.
Novartis Technical Operations
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Senior QA Operations Specialist

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