Join GP Pharm as a Senior QU! **Job Mission:** Ensure strict compliance with regulations (GMP, GxP, 21CFR) and guarantee that each batch released from our plant meets approved specifications and established quality requirements. What will you do on a daily basis? As a Senior Quality Unit member, your responsibilities will focus on: * Quality Management System (QMS): * Quality Events: Lead investigations into deviations, OOS, and complaints, ensuring robust root cause analysis and effective CAPA implementation. * Change Control: Assess the impact of proposed changes and oversee their correct implementation and closure. * Documentation: Review and approve quality system documentation. * Review of manufacturing and analytical instructions: Final review of batch documentation prior to release. * Validations (Process and Cleaning): * Manage the lifecycle of product process validations and aseptic filling validations (Media Fills). * Draft and/or review corresponding protocols and reports. * Data Analysis and Trending: * Prepare Product Quality Review Reports (PQR). * Monitor and evaluate trends in quality KPIs, environmental monitoring, and water quality (WFI/PW). * Audits and Compliance: Participate in preparation and hosting of Health Authority inspections/customer audits and follow-up on resulting actions. The selected candidate will not manage all tasks; these will be assigned depending on experience and background. What are we looking for? * University degree in pharmacy, chemistry, engineering, biology or biotechnology * Professional experience in a GMP area within the Pharmaceutical Industry of at least 3\-4 years. * Minimum English level FCE. **Additional Information:** * Location: Sant Quintí de Mediona (own vehicle required) * Contract type: Permanent * Working hours: Flexible core hours * Flexible compensation Why work at GP Pharm? GP Pharm Culture At GP Pharm, our culture promotes equality, flexibility, and trust in people, prioritizing both professional and personal well-being. Our values guide everything we do and enable sustainable growth, always keeping focus on patients, quality, and the efficacy of our products. **Mission:** Improve people's health and quality of life by manufacturing highly complex injectable products accessible to everyone worldwide. **Vision:** Become the most reputable and reliable pharmaceutical company for our patients and partners, nationally and internationally, providing the highest quality injectable products through sustainable growth that reduces environmental impact. **Values:** **Achievement:** Our results-driven culture pushes us to achieve excellence in everything we do. We set demanding goals to ensure our products are effective and safe, working in an agile and methodical way to deliver results exceeding expectations. **Innovation:** We strongly commit to innovation as a tool for continuous improvement. Research enables us to develop solutions that transform patients' lives and drive progress in the pharmaceutical industry. **One Team:** At GP Pharm, we work as one team, fostering trust and communication. We share a common vision and collaborate to achieve our goals. Mutual respect and joint effort are essential for our collective success. \\\#wearegppharm