GP Pharm is a privately owned pharmaceutical company founded in 2000. Its pharmaceutical manufacturing plant is located in Sant Quintí de Mediona (Alt Penedès). The company specializes in injectable products, including drug delivery systems based on microspheres, liposomes, and lipid nanoparticles. Our main therapeutic areas of interest are Oncology, Urology, and Women’s Health. * Collaborate in compliance with GxP regulations, “21 Code of Federal Regulations (CFR) Part 4”, and specifically section 820.20(b)(3) for the manufacture of medical devices and combination products. Participate in the company’s continuous improvement processes and comply with occupational risk, safety, and hygiene guidelines. * Collaborate in the drafting and review of documentation generated by the Quality Unit and other departments. * Coordinate the distribution of approved documents, as well as the withdrawal of obsolete documents. * Maintain up-to-date the archive of original documentation stored within the department (in both physical and electronic formats). * Manage and conduct relevant self-inspections, and collaborate in implementing related corrective actions. * Collaborate in preparing for and responding to inspections by health authorities and customer audits. Collaborate in implementing resulting corrective actions. * Participate in deviation investigations; review and manage those assigned to you. * Track corrective and preventive actions, and implement those assigned to you. * Participate in change control assessments and collaborate in closing change controls. * Draft and maintain the Master Qualification and Calibration Plan. * Draft the Annual Qualification and Calibration Plan according to the current Master Qualification and Calibration Plan. * Manage and/or perform equipment qualifications and calibrations, and draft corresponding protocols and reports in accordance with the current Master Qualification and Calibration Plan. * Manage and/or perform facility qualifications, and draft corresponding protocols and reports. * Provide support and ensure proper operation of equipment and facilities when required. * Support other tasks assigned to the Quality Unit department, as well as support the rest of the team when necessary.