Role DescriptionIn this role you are responsible for monitoring and maintaining the quality (compliance) of bulk products, finished products and packaged products such that the EU GMP, the registration dossier, the national legislation (commodities law) and the organization guidelines are met.
Responsibilities- Supervising (subject matter) the products entrusted (part of the range), both routinely and during deviations or questions with a view to ensure compliance and quality - Assessing and supervising the introduction of new products and product changes (Change Control) - Guiding and preparing documentation when placing products with a new contract manufacturer (Site Change) - Manage ongoing stability program - Supporting the Qualified Person within (inter)nationally set stringent standards and company regulations - Participate in audits at contract manufacturers together with the QP or Director QA - Participate in projects
Requirements- BSc. pharmacy - Experience in deviations and outs of specs (OOS) in production processes - Experience with pharmaceutical analysis methods - Knowledge of European GMP guidelines - Knowledge of the applicable European Registration Guidelines - Excellent English
Other informationAre you capable of maintaining the quality compliance according to the GMP, the national and the organization guidelines? Let me know and maybe you will be the lucky person with a new position at an interesting pharmaceutical company.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Ria Bos.