Q.c. compliance specialist - lims expert

Q. C. Compliance Specialist - LIMS Expert Department: Global Operations & Production Job ID: 45205 Our people in Manufacturing & Global Operations share two priorities: getting things done and making things better. If you’re a dynamic person with a positive mindset, you’ll fit in well here. It’s an international team with a powerful spirit of collaboration. Together, we make sure our products meet the highest standards of quality by constantly searching for ways to improve at every stage of our value chain – from the raw materials we buy through to the logistics network that brings our medicines to patients. Join our team and help us make an even bigger contribution to Grünenthal’s future. What the job looks likeYou will work within the Quality Department as a Business Process Expert of LIMS Design specification, customization and configuration of LIMS in order to satisfy the business requirement PQ validation tests of LIMS system Setting of master data in LIMS Support on LIMS relevant topics after go-live for all business departments Support on LIMS relevant topics for all business departments Workshops and daily meetings with cross functional and international teams Training on Qualified Persons and QC analysts Daily collaboration with Business Process Owners, Business Process Managers, IT consultants, and Project Managers to carry on the project Support digital roadmap implementation on Quality Control project Process mapping of Quality Control processes Fit-gap analysis between processes in the headquarter and the local sites Writing and reviewing of project documentation: flowcharts, Blueprint, SOPs, User Requirements, Risk Assessments, Validation documentsWhat you'll bring to the tableExperience in a similar role, such as BPE or LIMS Key User within pharma companies Familiarity with SAP QM Module is highly beneficial Fluency in Italian and English Previous experience in a pharmaceutical manufacturing site in Quality Control Department is beneficial Excellent communication skills, Problem solver, agility, willing to work in a fast-paced environment Knowledge of validation techniques (GMP; GAMP; WHO, CFR21…), risk management, data management, data integrity knowledges