QA Manager
As Quality Assurance Manager in the area of qualification / validation within Internal Quality Operations you will be responsible, among other things, for technical support of improvement projects in our production plants and you will also actively help to work through the daily routine as a QA Manager (e.g. processing deviations and changes).
QA for Functions handles all areas of aseptic manufacturing (Drug Product), production of solid drug forms (Drug Product) and packaging (market production and clinical trials).
Duration: 13 months
Location: Basel
Workload: 100%
The perfect candidate has a degree in pharmacy, natural sciences, engineering or a corresponding professional training, combined with many years of professional experience in the GMP sector. 3-5 years of experience in pharmaceutical production, development or quality assurance, preferably in the field of aseptic manufacturing and/or packaging and/or the manufacture of solid dosage forms is required.
Responsibilities:
* Collaboration and support as QA in the respective technical transfer and launch teams (local and global teams).
* Collaboration in an optimization project of existing plants. This includes, among other things, the categorization of the URS requirements and the improvement of all systems in terms of data integrity
* QA responsibility for all qualification and validation (QV) aspects of the equipment, which take place as part of technical transfers and launches.
* Classification and approval of amendments and processing of deviations.
* Review and approval of GMP-related documents such as plans, reports, SOPs, deviation management, change management, CAPA (corrective and preventive actions), risk assessment.
* Local support in the implementation of global standards and requirements.
* Working closely with internal and external interfaces to achieve our ambitious goals for safety, turnaround time, quality, commitment and costs.
Requirements:
* Completed studies in the field of pharmacy, natural sciences, engineering
* Fluent German and English
* Min. 3-5 professional experience in pharmaceutical production, development or quality assurance, preferably in the field of aseptic manufacturing and/or packaging and/or the manufacture of solid dosage forms.
* Experience in qualification and a sound knowledge of data integrity requirements.
* High affinity for technical issues and GMP compliance around the topics of validation, plant and device qualification, computerized systems validation and data integrity.
#J-18808-Ljbffr