Sandoz is a global leader in generic pharmaceuticals and biosimilars. As a division of the Novartis Group, our purpose is to discover new ways to improve and extend people’s lives. We contribute to society’s ability to support growing healthcare needs by pioneering novel approaches to help people around the world access high-quality medicine. Our portfolio of more than 1000 molecules, covering all major therapeutic areas, accounted for 2015 sales of USD 10.1 billion. In 2015, our products reached more than 500 million patients and we aspire to reach one billion.
Job Type: Full Time
Experience: 3 - 5 years
Job Field: Pharmaceutical
Job ID: 222009BR
Business Unit: Commercial Ops SZ
Functional Area: Research & Development
- New Product Registrations: Prepares and submits documentation for application of drug registration in a timely manner and monitoring of the application during the evaluation phase to achieve a favourable outcome within agreed timeframes
- Maintenance of registered products: Support the DRA Manager, Sandoz in maintaining registration of currently approved products and timely submission of documentation for renewal of registration.
- Prepares, submits and monitors variation packages to the health authority and ensures timely approval
- Prepares & submits CDS update and PSUR to the health authority and ensures safety update is implemented if required
- Prepares text master and final artwork master in accordance with local labelling regulations and Sandoz internal requirement
- Ensures the implementation of Company corporate Quality Standards in the RO to be compliant with Novartis Quality standards/Sandoz Standards.
- Ensures full QA support for all QA related activities.
- Assist in ensuring that all aspects of the handling and distribution of pharmaceutical products at the site/in the country and all other QA related activities comply with the requirements of the Novartis Quality Manuals (QM), Sandoz GOPs and internal company SOPs
- Ensures implementation of relevant Sandoz d.d. SOP to the RO organisation
- Ensures that compliance is maintained for Quality System and all Standard Operating procedures (SOPs) are in place for all GXP related activities
- Assists in ensuring adequate escalation process up to the management according to escalation management
- Maintains knowledge of local and international regulatory and legislative requirements and trends to ensure technical support on all quality related aspects to the RO
- Ensures all product specific annexes and QA agreement with each sites are updated and approved
- Assists in ensuring that all activities related to complaints, market action/recalls are performed in accordance with the relevant QM and are in compliance with the local regulations and Sandoz standards
- In case of any local third party coordination of the following activities with Sandoz d.d. responsible person: Audit and Quality Agreements with 3rd parties. Ensures coordination of third party activities (re-packaging, re-labelling , storage and/or distribution in way that all activities on 3rd party site are in compliance with Sandoz standards