Менеджер з якості

«ФАРМА ПЕРСОНАЛ»- спеціалізоване рекрутингове агентство

 Quality Principal Specialist Ukraine & CIS 

Роботодавець: Міжнародна фармкомпанія

 Job responsibilities:

• Organize and maintain the effective functioning of the quality system based on the results of self-inspections and analysis of the functioning of the quality system.             
• Organize and maintain the process of developing and managing documentation in accordance with the requirements of legislation and corporate company policies, standards and procedures. Develop quality system documents.
• Coordinate the work of Baxter employees in the corporate electronic documentation system, have the necessary access to post documentation and approval in the system.
• Coordinate the process on certification and declaration of the company's products to ensure uninterrupted production of products in accordance with the legal requirements of Ukraine and CIS countries.
• Organize and maintain the training process for company employees in Ukraine and the CIS in the field of quality assurance. Coordinate the training of company employees in Ukraine and the CIS in a corporate computerized system.
• Responsible for the Complaints review for potentially noncompliant medicines of the company in Ukraine and the CIS.
• Responsible for the Complaints process for Baxter medical products.
• Receive information from the FA Baxter Corporate Committee regarding measures taken in relation to products in public circulation to reduce health risks or improve product compliance with established requirements.
• Act in accordance with the action plan established by the FA Corporate Committee in accordance with corporate procedure
• Organize and maintain a process for dealing with inconsistencies and deviations from regulated, approved processes.
• Perform the necessary operations on the quality assurance side in accordance with the requirements of Baxter quality procedures in the JDE electronic system for Ukraine and the CIS countries.
• Conduct a timely legislation review of changes for Ukraine and the CIS in the field of circulation of medicines and medical devices in order to promptly inform Baxter divisions and make appropriate changes to processes.
• Implement risk management principles in the company.
• Organize and conduct self-inspections of CQA.
• Participate in audits of suppliers and audits of distributors (as an auditor and lead auditor)
• Organization of GMP inspection of manufacturing sites, maintenance of GMP recognition in Ukraine.
• Review and analyze the functioning of the quality system. Monitor and analyze trends in the functioning of quality system elements, provide reports to the manager every 6 months. Based on the analysis, propose measures to improve the functioning of the quality system.
• Promote compliance with the KPIs established in the company. Monitor key performance indicators of the department, submit reports to the management.
• Participate in the preparation of Quality Review every six months.
• Timely provide reporting related to the performance of prescribed form and within the time limits determined by the provisions (policies, orders, regulations, instructions) of the relevant divisions of the Company.
• Comply with the requirements of the Rules for the proper storage and transportation of medicines for medical use.
• Complete the procedure for annual performance assessment and goal setting in accordance with the rules and deadlines established by the Company. 
• Support the process of Suppliers’ Qualification.
• Compliance support of regulatory processes, lab testing organization and management.
• Other projects support from local quality perspective, like serialization etc. 

 Вимоги: 

• Вища освіта (фармацевтична, медична, хімічна, біологічна);
• Досвід роботи на аналогічній посаді від 3-х років;
• Досвід у зборі, систематизації та аналізі великих обсягів інформації;
• Вміння працювати з базами даних та комп’ютерними програмами MS Office
• Володіння англійською мовою - Intermediate.
• Грамотність, організованість, відповідальність, уважність, орієнтованість на результат

 Пропозиція компанії: оговорюється індивідуально 

Ваше резюме надсилайте за адресою: [email protected]

Тел.: (067) 900 88 75 Оксана