The Qualified Person is responsible to ensure that licensed Finished Product is certified and released to market by a Qualified Person named on the commercial manufacturing license in accordance with EU directive 2001/83/EC, 2004/94/EC and in accordance with the requirements of Annex 16. To ensure that investigational medicinal product (IMP) is certified and released to sponsor by a Qualified Person named on the IMP Manufacturing License in accordance with EU directive 2001/20/EC and in accordance with the requirements of Annex 16 and Annex 13.
Purpose: Perform, review and manage assay development, characterization, optimization, transfer, validation and investigation for QC chemistry or QC Biochemistry group....Apply For This Job
Purpose: Responsible to provide broad Quality Assurance expertise and leadership as required with an understanding of local regulatory as well...Apply For This Job
Purpose: Position is responsible for the quality oversight of distribution of company products world-wide. Position will execute QA Distribution release...Apply For This Job
Purpose: Reporting directly to the Quality Assurance Manager, as a critical leader, you will play an integral role within a...Apply For This Job
Purpose: The Senior Specialist Technical Services has primary responsibility for providing technical support of commercial and clinical drug substance and...Apply For This Job
Purpose: The position is accountable for timely completion of technical transfer related milestones, with particular emphasis on new product introduction,...Apply For This Job