Quality Director

Job Description : PHARMA QUALITY DIRECTOR FRANCE Open to International bi lingual candidates leading group in the subcontracting market, the site for which we are recruiting specializes in aseptic filling. Reporting directly to the Site Director, as Quality Director and Responsible Pharmacist, you will be part of the CODIR and your main missions will be as follows: Implement and develop the site's Quality policy, be a driving force in a process of improving Quality Ensure compliance with Good Manufacturing Practices (GMP) and CGMP on the site Ensure the management and good performance of the site's quality department, made up of around 65 people (quality assurance, quality control, qualification and validation, sterility assurance, projects, etc.) Ensure product quality, safety, efficacy, identity and purity Certify the physicochemical, microbiological, toxicological and immunological quality of components, semi-finished and finished products as well as that of their environment of use Develop and implement the Quality Assurance policy, in line with the general strategy of the UAP and that of the group's Quality Department Define the organizational methods, lead and coordinate the activities of the Quality department, according to the established policy Ensure the robustness of the quality system Be the preferred contact for inspectors and regulatory agencies on site for carrying out inspections and monitoring actions Carry out stage confirmation or certification for pharmaceutical release in the absence of the Pharmaceutical Release Manager. Pharmacist with a PhD and registered in section B of the Order, you have at least 10 years of experience in quality functions in the pharmaceutical industry (laboratory or CDMO). You must have managerial experience of large teams, as well as excellent knowledge of international pharmaceutical standards (including FDA). Your previous experience on sterile products or aseptic filling will be greatly valued for this position. Your level of English is fluent in order to interact easily with international contacts. Finally, your leadership, your ability to unite and more generally your interpersonal skills will be assets to manage the quality department, while becoming a key contact both internally and with external partners. Our client will also be sensitive to your strength of proposal and your ability to challenge projects and anticipate issues.

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