Life Science Consultant: CSV, SAP Validation

Life Science Consultant: CSV, SAP Validation Location: Remote The purpose of the role is to work with our clients to understand their needs, offer advice, solve problems, manage change, and improve efficiency. Responsibilities: Must be well versed in one or more SAP systems, preferably SAP ChaRM. Approval of normal and urgent transports in ChaRM (review of previous test-evidence). Review, coordination, eDMS upload and approval of ticket related document updates of the following types: SCD FDS TDS (OQS) Document update guidance, review, approval, eDMS workflow for the following types: PFs BBP URS RA FDS TDS OQS PQS TMX Supporting Life Cycle Documentation Regular update and eDMS Approval of TMX, TML. Regular review and upload of updated URS, RA, SCD. Scheduled meetings (Status Calls, DAB, workshops). Execute test review and approval workflow. Supporting ChaRM – Change Management Part of the virtual team in supporting Global IT Quality. Liaise with global IT quality and local quality to be the owner of local IT Quality Policies (QAP), quality-related operation process (SOP), tools, and standards to the stakeholders (e.g., Business, Global Functions, Global Site IT) Develop/maintain quality procedures along the life cycle of in-scope computerized systems Keep compliance information in ITSM tool updated, Site IT risk register, and associated mitigation activities Support project activities as IT Quality Assurance, for local GxP IT projects Support IT lifecycle processes such as change control and document management Provide training related to IT systems quality and compliance Support Site Business, when needed, as an extension of Site Quality and Global IT Quality, for the topic of Data retention, Data Privacy & Electronic Change management process Plan and implement qualification and computerized system validation (CSV) activities as well as projects of new and existing regulated computerized systems according to internal and external requirements for all departments Support application and infrastructure classifications (GxP versus non-GxP) Develop and approve specific computer system validation documentation such as quality, validation, and test plans and report. Minimum Qualification And Experience Education Bachelor or Master’s degree in IT Technology, Life Sciences, Computer Science, or similar fields. Language Business English required Work Experience 5 years of experience in Computerized System Validation within Life Science Industry Hard Skills Experienced in Computerized System Validation, such as but not limited to SAP, MES, LIMS, TrackWise, Veeva, etc. Must have knowledge of CSV regulations and standards Knowledge of regulations and standards such as GAMP5, ISO, ICH, EudraLex, FDA, EMA, WHO, PIC/S, and SOX Practical experience in and passion for information governance, IT quality and compliance, and service management. Soft Skills Excellent people management, leadership, and decision-making skills. Ability to facilitate a holistic perspective and understand business needs. Motivated to continuously expand her/his knowledge of the life science industry. Strong communication and problem-solving skills. Ability to work globally to coordinate the work of associates at all levels. Considerable organization awareness (e.g., the interrelationship of departments, business priorities) including experience in working cross-functionally and in global teams across cultures. We Offer Great Benefits Flat hierarchies and responsibility from the beginning People-oriented culture Diversity and inclusion-focused environment Global client projects in a multinational environment Flexible working hours and home office Involvement in global conferences Individual professional development, training, and coaching Contact If you have the necessary background and experience and would like to join a small team responsible for a truly global operation, then please send your application to recruiting(at)kvalito.ch including your: CV, cover letter, and supporting documents (i.e., diplomas, certificates, references) Availability – earliest start date Salary expectations Location preference We are looking forward to your application. Your KVALITO Team. J-18808-Ljbffr