Quality Assurance and Regulatory Affairs Associate (m/f)

REFERENZNUMMER:

277712/1

IHRE AUFGABEN:

-Activities concerning SOP system, Quality Manual and related
-Activities concerning deviation and change control system
-Corrective and Preventive Actions (CAPA)
-GMP/product quality decisions in conjunction with regional quality teams
-Warehouse and distribution activities
-Plan, coordinate, control and take care of all activities needed to obtain and maintain registration
-Evaluate and submit registration files in order to obtain the market authorization (MA) in the best time frame
-Submit variation files to enhance the Life Cycle Management (LCM)
-Periodic Update Safety Reports (PSUR) submission and follow-up on Monitored Release (MR)
-Coordinate Dear Doctor or Pharmacist Letter (DDPL) and Dear Investigator Letter (DIL)

IHRE QUALIFIKATIONEN:

-Master Degree in Pharmacy, Chemistry or Biochemistry
-Strong knowledge of GMP/GDP
-Experience within quality, compliance, regulatory or laboratory units
-English, German and French skills

WEITERE QUALIFIKATIONEN:

Quality manager