Description: Founded over 40 years ago by Samih Darwazah in Jordan, Hikma’s purpose is to provide high-quality, affordable medicines to the people who need them. Built on very solid foundations, we continue daily to innovate and find practical solutions to transform the lives of the millions of people we serve. In the late 1980s, we expanded our reach into the U.S. and Portugal by building a manufacturing facility for injectable pharmaceutical products. This was a pivotal turning point for the company and marked our first steps into new regions. Today, in Portugal, we employ over one thousand people and operate three manufacturing facilities for injectable medicines. Hikma is seeking a **Quality Associate I, Quality Systems** (m/f) to join the **Quality Systems Department**, in an on-site capacity. **Key Responsibilities:** * Generate investigation reports and trend analysis reports related to quality complaints (customer and supplier complaints). * Conduct risk assessments in accordance with the current Quality Risk Management approach. * Monitor KPIs and prepare reports for the Corporate and Quality Boards. * Manage Change Controls – enter information into the database, track pending actions, and archive all closed Change Controls in the SAGE/X3 system. Oversee all open Change Controls in the Veeva QMS system; issue Red-tags, Stop Notices, and Risk Assessments for batch release. * Act as DocController in Veeva DMS – oversee document closure through review of metadata fields; maintain an organized database and track documentation to ensure its completion, approval, and effectiveness. Support the semi-annual review of SOPs and templates, and issue controlled copies. * Deliver individual training on updated procedures, in line with the approved training plan. **Profile:** * Bachelor’s degree, preferably in Pharmaceutical Sciences. * Professional experience or training in Quality or within a hospital pharmacy setting. * Good command of the English language. * Knowledge of applicable regulations and guidelines. * Strong sense of responsibility. * Ability to multitask and be highly organized. * Demonstrated time management skills and flexibility in setting priorities. * IT proficiency, including experience managing databases, is an advantage. **We Offer:** * Temporary employment contract. * Remuneration commensurate with responsibilities. * Excellent career prospects. If you believe this is a great opportunity for your professional career, join us and contribute to **Better Health, within everyone's reach, every day**. Location: Sintra, Sintra, PT