Specialist (m/w/d) Batch Record Review - 1 Jahresvertrag in Teilzeit 80%

Rentschler Biopharma Se Job Post Advancing medicine to save lives. Together.Thanks to many decades of experience and our passion for what we do, we make an essential contribution to the global availability of biopharmaceuticals, especially for patients with rare and serious diseases.Rentschler Biopharma SE is a leading contract development and manufacturing organization (CDMO) focused exclusively on client projects. We offer customized full-service solutions for bioprocess development and the production of complex biopharmaceuticals. As a German family-owned company with an international footprint and global reach, we combine experts, expertise and years of experience to develop best-in-class solutions – together with our clients.Rentschler Biopharma has approximately 1,400 employees and is headquartered in Laupheim, Germany, with a site in Milford, MA, USA. In 2024, we joined the United Nations Global Compact, underlining our commitment to sustainability.As an independent family-owned company, we live by the motto: Many hands, many minds - ONE TEAM! Open, respectful cooperation characterizes our working environment, where quality awareness, diligence and responsibility are our top priorities. With all the diversity of our talents in the Rentschler team, we pursue one vision together: advancing medicine to save lives.Responsibilities And Duties Responsible for the timely technical review of manufacturing documents for active substance production (upstream and downstream) in compliance with GMP requirements. This includes:Review of documentation for accuracy, completeness, and traceabilityVerification of calculations, balances, and raw dataReview of data in LIMS and SAPIndependent clarification of identified observations in close collaboration with the respective departmentIndependent information dissemination and coordination of any necessary correctionsInitiation of deviation processes if requiredDerivation of measures, e.g., production-internal trainingSupport in the creation and modification of SOPsSupport in cross-departmental and internal projectsTraining of new employees and supervision of internsWhat We Value Completed (scientific) vocational training with professional experience or a comparable qualificationGood understanding of processes in active substance production (USP / DSP)Experience in GMP-compliant documentation is desirableIndependent and timely workTeam capability and motivationGood communication skillsFluent German and EnglishVery good PC skills (MS-Office)What You Can Look Forward To Meaningful work: Become part of a company that makes a real difference for seriously ill patients through the development and production of life-saving medicinesInspiring work environment: Experience the joy of working in a collegial atmosphere that promotes cooperation and team spirit on siteIndividual development opportunities: Access to personalized training programsCompensation: Attractive salary and annual performance bonus (equivalent to one month's salary)Flexible work arrangements: Flexible working hours, flextime account, options for remote work, 30 vacation days plus special leave daysShared breaks: Cafeteria with vegetarian/vegan optionsHealth: Corporate health management, company doctor, corporate pension planShared experiences: Team and company eventsEco-friendly mobility: Leasing options for (e-)bikes, e-scooters, and e-rollersFamily-friendly support: On-site childcare centerSecure job: Future-proof industryEmployee benefits: Numerous employee discounts (corporate benefits), job ticket discounts, financial support for relocation after a certain distance, free parking, comprehensive onboarding program