Quality Assurance Specialist (m/f)

REFERENZNUMMER:

298314/11

IHRE AUFGABEN:

-Ensure that products, systems and facilities are in state of sustainable compliance with the requirements of cGMP and regulatory authorities
-Responsibility for all quality matters related to the activities performed in the production and during process development
-Assure efficient and effective quality assurance activities at required cGMP level
-Assure that the products are manufactured according to cGMP requirements
-Review and approval of SOPs, WOIs, TEIs, FOBs, RARs and other quality related documents
-Ensure definition of appropriate and effective CAPAs with appropriate timelines and ensure timely implementation
-Perform QA release of batches and intermediates
-Set batch status in LIMS and SAP, excluding QP release

IHRE QUALIFIKATIONEN:

-Experience in quality assurance of biological or pharmaceutical products according to cGMP requirements
-University degree in natural sciences, medicine or pharmacy or professional scientific, medicinal or pharmaceutical training and profound working experience under cGMP
-Know-how regarding quality assurance principles (cGMP)
-Know-how of biological manufacturing processes
-Profound know-how regarding Quality Assurance
-Know-how of risk management
-Good negotiation skills
-German and English language skills, in both written and spoken form

WEITERE QUALIFIKATIONEN:

Quality manager