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Title: Quality Associate I, Quality Systems
Description:
Founded by Samih Darwazah over 40 years ago in Jordan, Hikma's purpose is to provide affordable, quality medicines to the people who need them. Based on solid foundations, we continue to innovate daily and find practical solutions to transform the lives of the millions we serve.
In the late 1980s, we expanded beyond the Middle East and acquired land in Portugal to build a sterile factory for injectable pharmaceutical products. This was a significant milestone, marking our entry into a new region. Today, in Portugal, we have over 900 employees and three factories producing injectable medicines.
Hikma is seeking to recruit a Quality Associate I, Quality Systems (m/f) to join the Quality Systems Department, with on-site work.
Main Responsibilities:
* Issuance of investigation and trend reports for quality complaints (from customers and suppliers)
* Preparation of risk assessments following the Quality Management Risk Approach
* Monitoring KPIs and preparing reports for Corporate and Quality Councils
* Managing Change Controls: entering information into the database, following up on pending actions, and archiving all closed Change Controls in SAGE/X3; overseeing open Change Controls on Veeva QMS; issuing Red-tags, Stop Notices, and Risk Assessments for batch release
* Acting as Document Controller in Veeva DMS: reviewing metadata, maintaining organized documentation, and overseeing finalization and approval processes; following up on SOP revisions and issuing controlled copies
* Approving infrastructure and maintenance forms
* Managing the Reserve Samples inspection/incineration program and scheduling annual inspections
* Issuing manufacturing process yields for products produced at Hikma Farmacêutica (Portugal)
* Providing individual training on updated procedures as per the training plan
Profile:
* Bachelor's degree or equivalent in Science
* Minimum 6 months of professional experience or training in Quality
* Good command of English
* Knowledge of applicable guidelines
* Strong sense of responsibility
* Ability to multi-task and stay highly organized
* Effective time management and flexibility in setting priorities
* Computer skills, including experience with databases, preferred
We offer:
* Direct contract with Hikma
* Competitive salary based on role
* Life and health insurance
* Annual Performance Bonus
* Excellent career prospects
If you see this as a great opportunity for your professional growth, join us and contribute to Better Health, accessible to everyone, every day.
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