acino.uaacino.uaacino.ua

Quality Assurance Manager

Qualification:

·        Higher pharmaceutical / biotechnological education;
·        Over 5 years of experience in work in the production, distribution, import of medicines.

Knowledge of:

·        Regulatory legislation of Ukraine for the pharmaceutical industry;
·        Production processes in quality provision: certification and release of finished products batches;
·        Guidelines and Directives of the European Union (GMP, GDP);
·        Policies of the World Health Organization (WHO);
·        Guidelines of the International Convention on Harmonization (ICH);
·        European database EudraGMP;
·        English on upper-intermediate level;
·        Computer skills at the level of an experienced user.

Required competencies:

·        Ability to work with large amounts of scientific information
·        Human resource management;
·        Analytical thinking;
·        Responsibility;
·        Competence;
·        Ability to influence others and integrity;
·        Time management skills.

Responsibilities:

·        Planning and carrying out quality audits of Third Parties to assess effectiveness of the quality management system, compliance with the requirements of GxP (Good Practices), current legislation and internal standards of the company.
·        Negotiation of Quality Agreements with a Third Party (with manufacturers, suppliers, distributors, subcontractors, etc.).
·        Planning and carrying out self-inspections (internal quality audits).
·        Control over implementation of corrective and/or preventive actions in the field of quality.
·        Analysis of deviations and unconformities that may affect quality of Products.
·        Quality risk assessment, analysis and management.
·        Participation in regular and periodic Product Quality Review.
·        Development of an Annual Quality Management Review.
·        Change control.
·        Monitoring and timely updating of documentation of the Quality Systems Department (Standard Operating Procedures, Policies, SMF).
·        Participation and control over implementation and testing of EDMS.
·        Assistance in State inspections, audits by Headquarters and partners.
·        Preparation of quality metrics reports.
·        Carrying out training for company's employees on compliance with GxP (Good Practices).

Please apply for position using following link:  https://rabota.ua/company927691/vacancy7938903