Are you passionate about technology and like to take on complex technical challenges? Do you want to work in exciting projects at renowned clients? At ALTEN we believe that knowing and meeting the expectations of our consultants is a key factor in our success. Our consultants make the difference. Do you want to make the difference too?
• Working experience within pharmaceuticals, biotechnologies or chemical industry
• Know-how of commissioning and qualification requirements according to (c)GMP regulations
• Know-how of quality assurance principles and experience working with cross-department stakeholders
• Experienced with GAMP5: Risk-based Approach to Compliant GxP Computerized Systems
• Know-how of ISPE baseline guide vol 3, vol 4 and vol 5 is a plus
• Plan, coordinate and execute all phases for qualification of GMP manufacturing systems including but not limited to, Qualification/Validation plans, FMEA, DQ, IQ, OQ, PQ.
• Prepare, review and approve technical and GMP related documentation (URS, impact/risk assessment, Master plans, qualification/validation documentation)
• Coordinate and execute FAT/SAT, commissioning activities for new manufacturing systems in collaboration with internal and external partner
• Bachelor/master’s degree in technical or natural sciences
• QPCR, Wireless glove tester, HPLC and N2 generator, Tecan, Nexgen, Endoscan
• Waage und Titrator
• Biosafety cabinets
• Climate chambers, hot air sterilizer, fridge, freezer, incubator
We are looking forward to getting to know you and your ambitions!