Aug 17, 2022

Job Description

26000+! That’s how many employees at Sandoz worldwide. We are a division of the Novartis Group and a global leader in generic and biosimilar medicines, committed to playing a leading role in driving access to high-quality and affordable medicine worldwide. Join us and pioneer access for more patients!

Your responsibilities include, but are not limited to:
• Ensure that all aspects of the handling, manufacturing and distribution of biopharmaceutical / pharmaceutical products are in compliance with the Novartis Quality
Manual, the effective Quality Agreement that they meet relevant GxP regulatory requirements and are conducted according to local SOPs.
• Prepare, review and check the batch documentation for correctness, completeness and safely archive the original documents for the prescribed period and plan, conduct and monitor self-Inspection schemes for all sections. Monitor actions and corrections accordingly.
• Conduct GxP monitoring on all sections, conduct QA investigation for noncompliance, follow up the corrective actions. Archive relative documentations and manage/Approve critical quality issues, according to the Quality Agreement and the Novartis Quality Manual. Ensure investigations are correctly executed. Ensure all required actions are taken appropriately and in a timely fashion.
• Escalate any issues or instances of instability per the Novartis escalation policy, and initiate any market action that is required. Decide escalation to Senior Management Level and lead Global Quality Assessments and manage filing accordingly as well as ensure that Change requests, are managed according to the Novartis SOPs from receipt, through to the implementation and closure.
• Responsible for assessing quality trends and driving continuous improvement for processes and product quality performance and maintain access to regulatory and Pharmaceutical authorities in respect to up-dated GxP ovide latest know how in the field of GxP and other
quality related fields. Identify repetitive activities and regulatory areas for which SOPs are required. Initiate the introduction of SOPs.
• Plan, initiate and monitor basic GxP-training for all employees in regular intervals. Be responsible for annually training program and implementation.
• Establish and maintain cross-functional contacts with peer organization and authorities and, follow-up quality related developments in the field of Pharmaceutical products
• Ensure that all drug products are released to the market in accordance with the registered specifications and with local/international regulations.

Diversity & Inclusion / EEO


Minimum Requirements

What you’ll bring to the role:
• Location: Beijing/Shanghai/Guangzhou
• Education:Bachelor degree or above in science or related major
• Fluent English required (oral & written). Good skills in site (local) language.
• Fundamental, broad understanding and knowledge of quality standards and policies in Drug Substance/Drug Product/Medical Devices manufacturing and control.
• Broad experience in technical drug development as well as in Quality Assurance and/or Quality Control departments. Experience in Technical Operations or equivalent experience from external company is preferred.
• Ability to contribute to matrix teams with the necessary strategic thinking, quality awareness and implementation skills.
• Computer literacy (e.g. MS Office, document management systems) demonstrated along with readiness to learn new systems and associated processes.

Why Sandoz?
500 million patients were touched by Sandoz generic and biosimilar medicines in 2020 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.

How will we do this? 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 Sandoz!

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 Group 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.
BioPharma SZ
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Senior QA Manager

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