Within Janssen R&D, a member of Johnson & Johnson's Family of Companies, we are recruiting a QA-CSC Associate, based in Beerse, Belgium.
In the Janssen Research & Development area we develop treatments that improve the health and lifestyles of people worldwide. R&D development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, pulmonary hypertension and reproductive medicine!
Our department QA-Clinical Supply Chain is responsible for the release and certification of investigational medicinal products used in worldwide clinical trials to guarantee patient safety & compliance with applicable regulations.
As QA-CSC Associate for the clinical release process, you will support release activities relating to the weighing, formulation, filling, packaging, QC testing and storage of Drug Products (DP) for use in clinical trials, manufactured at Beerse DP Pilot Plant and external DP manufacturers.
Support the operational quality performance by batch record review and release of Drug Product (solid, liquid and sterile formulations) for clinical use and sterile API for commercial use.
Support the management complaints and ensure that complaints are timely and properly investigated in order to meet internal and external customer expectations.
Support the management of deviations/CAPAs/Change Controls and complaints) and ensure that the quality records are timely and accurately investigated and closed in order to meet internal and external customer expectations.
Ensure Quality and Compliance operational targets are met.
Review and approve related GMP documents such as procedures and work instructions.
Contribute to process improvements within the QA organization together with the business partners thereby applying Quality Risk Management tools.
Support and act as spokesperson during Health Authority inspections and customer audits.
QualificationsYou have a master’s degree scientific orientation (pharmaceutical, chemical or biological sciences) with at least 1 year’ experience in the pharmaceutical industry.
You have knowledge and understanding of relevant pharmaceutical cGMP and GDP legislation related to Clinical Trial Material (Eudralex, ICH, Ph.Eur., USP, etc) at global, regional and national levels.
You have an in-depth understanding of pharmaceutical product development, qualification, manufacturing, packaging, validation, testing, release, storage and distribution processes.
You have excellent verbal and written communication skills to influence and communicate with external and internal customers and partners.
You have strong analytical thinking, decision-making and leadership skills.
You have competencies and experience in quickly assimilating new technologies, performing risk assessments and developing action plans.
You have experience with Quality systems. You understand business implications regarding quality positions and decisions.
You can work in a flexible way under time pressure and make difficult decisions in a timely fashion
You can work independently while staying connected with partners.
You have excellent communication and presentation skills across all levels.
You can influence partners without line authority