QA representative in NBE production projects, tech transfer, change control and deviations. Ensure the review and approval of product master batch record. Review and approve product specifications and standard operating procedures. Support the evaluation of NBE product manufacturing related deviations, CAPA, change controls, laboratory investigation and internal audit findings. Provide support for inspection by authorities, internal and external audits. Contribute in the optimization of quality processes based on GMP. Perform other relevant duties as required.
BSc, MSc or equivalent biochemical engineering, biochemistry, biology, pharmacy or related discipline At least 2 years of relevant experience in an industrial setting under GMP manufacturing conditions Relevant experience in biotechnology (quality management of USP/DSP recombinant monoclonal antibody production). QA experience and knowledge of current Swissmedic, EMEA, FDA, USP, EP and ICH guidelines Experience in tech transfer of GMP Manufacturing process (BDS/DP) to CMO is a plus Experience in change control and deviation management Strong sense of discipline, exceptional organization skills, excellent team orientation and hands-on approach to work Ability to work independently with proven experience in problem analysis/solving, anticipation and proactivity Fluent English both written and verbal; proficiency in French is highly desirable Autonomous, reactive and flexible to changing priorities