Job Summary: Hikma is seeking a Quality Associate I, Quality Systems (m/f) to manage quality systems and documentation, ensuring compliance and continuous improvement. Key Highlights: 1. Experience in Quality or hospital pharmacy is valued 2. Strong career development prospects 3. A critical role in quality and documentation management 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 to the US and Portugal with the construction of a manufacturing facility for injectable pharmaceutical products. This was a major turning point for the company and our first step into new regions. Today, in Portugal, we have over one thousand employees and three manufacturing facilities for injectable medicines. Hikma seeks to recruit a **Quality Associate I, Quality Systems (m/f)** to join **the Quality Systems Department**, in an on-site format**.** **Key Responsibilities:** * Issuing investigation reports and trend analysis reports related to quality complaints (customer and supplier complaints). * Conducting risk assessments in accordance with the current Quality Risk Management approach. * Monitoring KPIs and preparing reports for the Corporate and Quality Boards. * Managing Change Controls – entering information into the database, tracking pending actions, and archiving all closed Change Controls in the SAGE/X3 system. Supervising all open Change Controls in the Veeva QMS system; issuing Red-tags, Stop Notices, and Risk Assessments for batch release. * Acting as DocController in Veeva DMS – supervising the document closure process through review of metadata fields; maintaining an organized database and tracking documentation to ensure its completion, approval, and effectiveness. Monitoring the semi-annual review of SOPs and templates, as well as issuing controlled copies. * Providing individual training on updated procedures, in accordance 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 standards and guidelines. * Strong sense of responsibility. * Ability to multitask and be highly organized. * Demonstrated competence in time management and flexibility in setting priorities. * IT skills, including experience managing databases, are valued. **We Offer:** * Temporary employment contract. * Remuneration commensurate with responsibilities. * Strong career development prospects. If you believe this is a good opportunity for your professional career, join us and contribute to a **Better Health, within everyone's reach, every day**. Location: Sintra, Sintra, PT