Вакансии

  • Москва
  • Полный рабочий день

Quality Assurance Specialist

15 сентября 2016, 11:34

Responsibilities:
  • Ensures the maintenance of quality records, nonconformance, project outcomes, and that stakeholder input is filed in an accurate and timely manner;
  • Management and Review of the change control process, tracks the approval process / action execution;
  • Contributes to the development of corrective action / preventive action plans and monitors implementation;
  • Management of the nonconformance;
  • Reports on execution and closure of corrective and preventive actions, nonconformance, strong cooperation with standarts of company;
  • Performs GAP assessment evaluation against corporate standards and support process improvement implementation;
  • Monitors and Leads investigations, recognizes trends and presents reports for assigned quality processes;
  • Reviews reports on current quality systems and supports improvements in order to enhance quality;
  • Execution of Internal Audits within Company, assures preparation for External Audits and Health Authorities Inspections;
  • Support Escalation process of Quality Compliance matters;
  • Monitors trends, identifies issues, recommends and implements appropriate actions;
  • Develops implements and reviews Standard Operating Procedures, Work Instruction and other Quality Documentation;
  • Provide Quality support in Supplier Management process, assessment of suppliers based on Quality Assurance criteria, company quality policy, standards and local regulations;
  • Management of product complaints, timely reporting into local system, data trending;
  • Handling Customer Complaints.
Requirements:
  • Higher education;
  • A similar experience more than 2-3 years in the pharmaceutical company;
  • Experience in audit;
  • Fluent English language skills for internal and external communication;
  • Experience with the quality suppliers;
  • Experience with complex clients, work with complaints;
  • A clear and structured thinking;
  • Knowledge of Quality Standards, GxP regulations;
  • Good Communication skills.
Conditions:
  • The Company is offering competitive salary;
  • Life insurance;
  • Medical insurance;
  • Lunch allowance;
  • Fitness allowance;
  • Temporary contract (maternity leave position from 1,5 years).

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