**About us** ------------------ We are an industrial company **leading internationally in the field of biotechnology and advanced therapies, based in Donostia\-San Sebastián, with a major expansion project, an unwavering passion for science, and a commitment to excellence and people.** Our **purpose:** improving people's lives through revolutionary advances in biotechnology and gene therapy that cure rare diseases and cancers. With a philosophy of not only working together but growing together, our client's culture is based on honesty, excellence, leadership, involvement, ethics, and rigor. We are a **CDMO** (Contract Development and Manufacturing Organization) and **the trust placed in us by more than 40 biotech companies worldwide is our best endorsement.** We develop and manufacture viral vectors (lentiviral), being one of the European leaders operating in accordance with EMA and FDA regulations. Lentiviruses produced by VIVEbiotech are used for the treatment of various diseases including hematological and solid cancers, or rare diseases. **We are looking for you to join our Team!** ### **Your role** We are seeking a **QA Technician** to fill this key position reporting directly to the Head of Department. Your mission will be **to ensure that necessary activities are carried out within the company to comply with applicable “Regulatory Requirements” and the “Quality Management System” in Manufacturing and Quality Control activities.** Likewise, you will provide **active support in continuous improvement of the quality system and in the implementation of new computerized systems and technologies for the overall enhancement of VIVE’s Quality area.** ### **Your responsibilities** * Manage the execution of the Quality Management System: Change Controls, corrective and preventive actions (CAPAs), risk assessments… * Manage GMP documentation: Standard Operating Procedures, Master Formulas, Analytical Methods… * Provide active support in implementing new computerized systems in the Quality department (ERP, Document Management, and management of Change Controls, Deviations, and CAPAs). * Review and approve the execution of manufacturing instructions and analytical techniques. * Review materials and raw materials and approve them for use in production and quality control processes. * Take reference samples of materials and raw materials and verify QC sampling according to current specifications. * Support the execution of projects: product development, process validations, and report preparation. * Review the creation, deletion, and modification of materials and raw materials. * Support the execution of customer and regulatory audits. * Support the execution of projects: product development, process validations, and report preparation. * Support the execution of audits. * Comply with VIVE's safety rules and contribute to their continuous improvement by reporting incidents from your own area or elsewhere in the company when detected. ### **What we value in you** You are who we are looking for if you have: * Studies related to Pharmacy, Biotechnology, Biology, Biochemistry, etc., complemented with knowledge of Regulatory Compliance (GMP, etc.) * Training in Good Manufacturing Practices: EMA and FDA * Previous experience in the pharmaceutical industry in similar roles, with certification in Good Manufacturing Practices. * Experience in risk analysis and management, as well as in the use of computerized systems applied to the pharmaceutical industry, will be valued. * Additionally, you are a person oriented toward high quality (excellence and self-demand), organized and orderly. * You proactively provide ideas for continuous improvement and share your knowledge and experience to help achieve your department's objectives. * Ability to work effectively within a team and you are proactive. * You are responsible and rigorous in your work, demonstrating high work capacity under high performance demands and tight deadlines. * You consistently show a positive attitude towards change. * Residence in Gipuzkoa (or intention to relocate to the area) will be positively considered. ### **We offer you** * You will have continuous career development opportunities that will help you grow your talent throughout your professional journey. * You will participate in innovative projects undergoing constant technological updates. * You will receive a competitive salary commensurate with your profile for this position. * You will benefit from flexible working hours, with the support needed to balance your personal and professional life. * You will become part of an expert, young, dynamic, innovative, and enthusiastic team united by a common purpose: supporting our clients in advancing cures for diseases. * We will support your personal relocation process if you come from another region and wish to move to Donostia\-San Sebastián (accommodation, job placement for family members, school enrollment, …). * You will enjoy a professional work environment truly distinguished by our humanity and closeness, where diversity and inclusion are cared for. Diverse perspectives and your curiosity bring varied capabilities that strengthen our approach and drive our growth. * We are proud to offer equal opportunities. All individuals receive equal consideration for our open positions, without distinction based on gender, age, race, religion, identity, sexual orientation, origin, disability, or any other characteristic.