**Functions and Responsibilities** * Within the QA Systems \- Product department, you will be responsible for implementing and maintaining systems that ensure proper GMP compliance of products and processes (APQRs, SCV\&C, review and approval of documents and master data…). * Review and approve documents related to the lifecycle validation of manufacturing and packaging processes, equipment cleaning, and transportation of sterile and oral products in accordance with cGMP, FDA regulations, and corporate and local procedures. (VMP, VPP, RA, Control Strategy, PPQs, CPV, CTV, cleaning monitoring and their periodic reviews) * Review and approve documents related to the lifecycle qualification of equipment and computerized systems, facilities and utilities, and validation and verification of chemical and microbiological analytical methods in accordance with cGMP, FDA regulations, and corporate and local procedures. * Ensure GMP and regulatory compliance of all procedures associated with manufacturing, equipment cleaning, and transportation through the review and approval of documented content (SOPs). * Additionally, other functions performed within the department that will not be primary for this position include: * Design and implementation of periodic product reports (PQR/APR) for products manufactured at the Sant Cugat sites in accordance with cGMP, FDA regulations, and corporate and local requirements. * Review and approve documents related to the lifecycle validation of analytical methods and testing specifications. * Ensure GMP and regulatory compliance of content within the ERP system (testing specifications, standards, manufacturing recipes, and master data) **Requirements** * University degree in Chemistry, Biochemistry, Biotechnology, Pharmacy, or equivalent. * More than 5 years of experience in the pharmaceutical industry (preferred areas: Quality and/or Validation). * Essential training or knowledge in process/cleaning validation systems and aseptic technologies. * Highly desirable experience with Combination Products and associated regulations. * Fluent spoken and written English and Spanish. A person who quickly adapts to change, flexible, detail-oriented, organized, autonomous, and with strong communication, teaching, and empathy skills. * \#IamBoehringerIngelheim because… We are continuously working to design the best experience for you. Here are some examples of how we will take care of you: * Flexible working hours * Life and accident insurance * Competitive medical insurance * Investment in training and development * Health care support * Employee benefits portal * Smartworking If you've read this far, what are you waiting for? We want to learn more about you!