Qualified Person in Cãlãraşi

Profilo ricercato: Qualified Person SIAD Romania, a leading company operating in the production and sale of industrial, food, specialty, and medical gases, is looking for a highly skilled and motivated Qualified Person (QP) to join our team in Călărași. The ideal candidate for this position should meet the following requirements: Bachelor’s or master’s degree: Pharmacy; Experience on a similar position: not needed. Located in Călărași or nearby. Good English knowledge. Good PC knowledge (MS Office). Required skills and abilities: Technical and analytical thinking. Good communication skills. Ability to learn and develop professionally. Ability to adapt and work in a team. Job Responsibility: Responsible for the release of Medicinal Oxygen batches in accordance with the provisions of the Product Market Release Authorization and GMP rules. It is also an approving factor in risk management and analysis process for manufacturing the medicinal oxygen and annual review of released batches. Job description: Responsible to certify that each batch of products released for placing on the market has been manufactured and inspected in accordance with the requirements of the documentation underlying the marketing authorization and GMP rules. Responsible for checking the Standard File of the product series and for certifying the series of Medicinal Oxygen Finish Product, Active substance and Bulk Product based on the Certificate of Analysis and the Certificate of Conformity. Responsible for analyzing deviation recorded during the manufacturing process and monitoring the implementation of CAPA plan generated by the identified deviation. Responsible for initiating the Rapid Alert process if required. Responsible for the withdrawal of the product series from the therapeutic circuit, if necessary. Responsible to investigate together with the authorized persons, the results obtained outside the technical specifications and to participate in decision-making discussion required in this situation. SIAD Romania offers a motivating salary package, meal vouchers, transport reimbursement, subscription for current medical services, private medical insurance, access to training packages that support a continuous professional development.