Senior QA Specialist, Process Validation 80-100% (f/m/d)

pbLocation: /bThe actual location of this job is in Visp, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed. /ppWe are currently looking for a Senior QA Specialist (f/m/d) Process Validation for the expansion of our team here at our site in . In this role, you will be QA responsible for the compliance of process validation with main focus on Small Molecules including validation activities at scale, continued process verification and Product Quality Reviews (PQRs). /ppbWhat you will get: /b /plipAn agile career and dynamic working culture /p /lilipAn inclusive and ethical workplace /p /lilipCompensation programs that recognize high performance /p /lilipA variety of benefits dependant on role and location /p /lipThe full list of our global benefits can be also found on . /ppbWhat you will do: /b /plipEnsure the manufacturing processes: APIs and Intermediates are in a validated state during their whole lifetime according to Lonza procedures, and in compliance with regulatory guidance /p /lilipPreparation of comprehensive process specific Validation Master Plans, describing the individual studies required for process validation /p /lilipLeading the process validation teams including communication with customers /p /lilipPreparation of the validation protocols and reports for the studies performed at manufacturing scale /p /lilipAssessment of changes and deviations during manufacturing for their impact on validation /p /lilipPreparation and maintenance of a documented continued process verification plan /p /lipbWhat we are looking for: /b /plipAcademic degree in Chemistry or any related field /p /lilipSignificant experience in the area of small molecules manufacturing, preferably in a validation function as well as strong background in cGMP /p /lilipBroad knowledge of manufacturing processes in GMP environment /p /lilipExperience in interacting with all kind of interfaces within the organization as well as with regulatory agencies (Swissmedic, FDA etc.) /p /lilipFluency in English language is required; good German language skills are preferred /p /lilipManaging internal and external customer relations professionally and effectively /p /lipbAbout Lonza /b /ppAt Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of. /ppInnovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board. /ppbReady to shape the future of life sciences? Apply now. /b /p Reference: R77456