Quality Assurance Specialist

One of the leading European pharmaceutical company is announcing a vacant position for Quality Assurance Specialist. Please note, this is a maternity leave position

Main requirements:

• Higher education (chemistry, biology, medical, pharmaceutical, etc.)
• Advanced English is a must
• Experience in a similar position is an advantage
• Quick learner, result driven, action-oriented and full of energy

Main responsibilities:

• Support product release for distribution process for company's products relevant to the scope of  company activities, such as: check and translation of batch certificates, interactions with manufacturing sites, preparation of clarification statements for Health Authorities in Ukraine, including obtaining of clarification statements from manufacturing sites;
• Maintain organization of QA documentation as per applicable GxP requirements and company's standards (paper and electronic archive management, translations);
• Approve graphical designs of product packaging in electronic system according to relevant SOP;
• Assure, within scope of responsibilities, compliance with all aspects of activities related to quality assurance requirements of company Quality Manual, standard operating procedures and quality assurance policies and also to GxP applicable requirements, quality assurance relevant legislation of Ukraine in scope of company activities;
• Maintain processes related to quality assurance system accordingly to adhere Key Performance Indicators established by company Quality Group. Report on the results of activities and key performance indicators to functional manager in Ukraine;
• Support the readiness of the Company for all GxP regulatory inspections and internal GxP audits;
• Participate in projects related to continuous improvement of quality assurance system initiated by quality assurance function;
• Timely inform about all GxP incidents in accordance with relevant SOP;
• Comply with the GxP quality requirements applicable to the area of responsibility, incl., but not limited to proper reporting of adverse events and customer complaints, samples handling as well as any incident that may adversely affect the quality, safety, identity, strength, purity, availability or efficacy of a commercial product or clinical trial material and/or may compromise company Quality System and the global reputation

Company offers a competitive salary rate, social package (including annual bonus, medical insurance, corporate meals, variety of knowledge sharing and training opportunities, etc.), ability to work within well-known products, and personal development.

If you meet the requirements, please apply to Отправить резюме