Директор з якості

«ФАРМА ПЕРСОНАЛ»-спеціалізована агенція

Quality Assurance/Quality Control Director

Роботодавець:  Грузія, Тбілісі, фармкомпанія –виробник лікарських засобів

Функціональні обов'язки:

 Oversees work processes used throughout the organization to assure that they conform to established standards.

Manages changes in systems or procedures when necessary to improve quality or maintain compliance.

Researches quality or compliance issues and recommends changes for improvements. Disseminates information on compliance requirements and initiatives.

Responds to requests from regulatory agencies. Leads in the creation of reports and documentation needed for regulatory bodies.

Sets standards for quality as well as health and safety

Defines quality procedures in conjunction with operating staff

Monitors and advises on the performance of the company’s quality system, produces data and reports on performance, measuring against set standards.

Liaises with other managers and staff throughout the organization to ensure that the quality system is functioning properly.

Where appropriate, advises on changes and their implementation and provides training, tools and techniques to enable others to achieve quality.

Devises and establishes company's quality procedures, standards and specifications

Reviews product specifications and ensures that they are met

Works with procurement staff to establish quality requirements from external suppliers

Makes sure that manufacturing or production processes in house and at external manufacturing facilities meet international and national GMP standards

Sets up and maintaining controls and documentation procedures

Monitors performance by gathering relevant data and produces statistical and Key Performance Indicators reports

Oversees internal audits, vendor audits and vendor qualification, corrective and preventive action system, non-conforming materials, Material Review Board, calibration program, and document control.

Oversees product quality reviews, management reviews and preparation of quality reports.

Ensures that all projects and validations are in compliance with requirements.

Ensures dependable and timely results from quality control, including process control and support for process changes in compliance with requirements.

Participates in regulatory inspections and customer audits.

Identifies and implements opportunities for continuous improvement.

Interacts and coordinate activities with other departments, external vendors and customers.

Evaluates the performance of the Quality Department employees with the intent of increasing their competency.

Collaborates with other departments to direct compliance issues to appropriate existing channels for investigation and resolution.

Responds to alleged violations of rules, regulations, policies, procedures, and initiates investigative procedures.

Ensures proper reporting of violations or potential violations of GMP or regulatory standards to corporate Quality Assurance as appropriate and/or required

Ensures that compliance issues/observations/concerns within the organization are being appropriately evaluated, investigated and resolved.

Works with the Human Resources Department and others as appropriate to develop an effective compliance training program, including appropriate introductory training for new employees as well as ongoing training for all employees and managers.

 Вимоги:

• освіта: вища (профільна)
• досвід роботи в сфері якості від 5 років обов'язковий
• володіння англійською мовою на рівні  intermediate обов'язкове (співбесіда англійською) 
• готовність до релокації в Грузію 

Пропозиція компанії: оговорюється індивідуально

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Тел.:  Показать контакты (067) 900 88 75 Оксана