Quality Assurance Specialist
Firmenname für PREMIUM-Mitglieder sichtbar
This is a contract role till end of December 2020 and based in Switzerland.
* Ensure that CMOs are using the correct specifications and methods
* Write equivalence reports internally and for CMO testing monographs
* Review testing methods where equivalence cannot be granted and provide smart solutions
* Responsible for writing and coordinating Agile Change Requests AQWA (track wise) actions/deviations/quality events
* Ensure that coordinated contact is maintained with other functions within Novartis also dealing with external suppliers namely Purchasing, Legal, Supply Chain, Regulatory CMC, Drug Regulatory Affairs, Group Quality Operations etc.
* Supporting authoring and review of technical documents (registration common technical documents, method validation protocol/reports, risk assessments, technical health authority responses etc.).
* Ensure testing monographs (TMs) for starting materials, chemical intermediates and drug substances (for transfers/launches only) are state of the art and with respect to technique and technology and in line with registration documentation. Support change control to upgrade testing monographs.
* Partner with QC and MS&T to support the product lifecycle.
* Ensure that coordinated contact is maintained with other functions within Novartis also dealing with external suppliers namely Purchasing, Legal, Supply Chain, Regulatory CMC, Drug Regulatory Affairs, Group Quality Operations (GQO), etc..
* Support Launch and transfer Project QAMs regarding interpretation and review of analytical data/reports.
* Participates and/or prepares cGMP audits of external contract laboratories and supplier/CMO laboratories, as required.
* Leads sourcing of new potential analytical contract laboratories.
* Review and approve validation protocols and reports across the external supply launch and transfer portfolio upon request from QAs and MS&T..
* Support site readiness for Health Authority inspections. Participate in audits of Contract labs or routine inspections of Contract Manufacturers/Suppliers on request.
* 3-5 years of experience working in the pharmaceutical industry with strong analytical background (Testing methods for API analytics)
* experiences in managing and executing tasks in product and method transfers
* Understanding risk assessment methodology
* knowledge of systems such as Trackwise (AQWA), Subway, Agile desirable
* sound knowledge of GMP guidelines (EU, US, ROW)
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