We are in important position to ensure stable and sustainable supply of good quality products from global / local manufacturing sites for our patient in Japan. You will be an important gatekeeper to maintain the good quality pharmaceutical product, and also to improve the product quality to meet our customer expectation.
Your Key Responsibilities:
Your responsibilities include, but not limited to:
Based on Novartis Quality Manual and Policies, you will maintain regulatory compliance under GxP/QMS guideline and local regulation, stable supply of high quality products to our patients, and getting customer satisfaction from quality point of view.
What you’ll bring to the role:5
You will be responsible person to ensure Quality Management System (QMS) for GQP in ASPEN QA organization.
· Implementation and maintenance the local SOPs / Working Instructions which are harmonized NCQ-J (IM/Sandoz/Aspen), in accordance with the Novartis Quality Manual, and the local regulatory requirements.
· Management of quality information such as customer complaint, deviation, and quality event.
· Management of GxP change control.
· Management of other GQP requirements by local regulation.
· Leading process improvement of QA activities collaboration with other QA division member in NCQ-J.
You’ll receive: (not mandatory)
· Completely flexible working style
· Various learning and development opportunities of a multi-national company
· Novartis corporate-wide fringe benefits
Why consider Sandoz?
Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic. And we never stop asking: how can we continue to pioneer access in an ever-more digital and global world?
The answers come when curious, courageous and collaborative people are empowered to ask new questions, make bold decisions and take smart risks.
Sandoz, a Novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics.
Imagine what you could do at Sandoz!
Commitment to Diversity & Inclusion: Sandoz, a Novartis company, embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
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