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Description Overview

Our team in Ukraine have an exciting opportunity for a Quality Systems Project Manager to join us. You will perform the duties of a Qualified Person (QP) in the import and wholesale trade of medicinal products and ensures all necessary actions for the development, implementation, maintenance, and continuous improvement of quality systems for medical devices, cosmetics, food supplements and biocides.

Scope of the Role

You will be responsible for:

  • The effective functioning of the pharmaceutical quality system;
  • An import of medicinal products in such a way as to ensure their compliance with the requirements of the registration dossier and to exclude the risk to patients associated with insufficient safety, quality or effectiveness of medicinal products;
  • The release of imported medicinal products for sale after confirmation, that each imported batch of medicinal products produced outside of Ukraine must undergo quality control in Ukraine in accordance with Ukrainian legislation;
  • An approval of written procedures including procedure ensuring management of external (outsourcing) activities;
  • Taking precautionary measures to avoid possible deviations that may occur in the future;
  • The management of the change control;
  • An applying an appropriate level of root cause analysis when investigating deviations, suspected product defects and other issues (including the use of quality risk management principles);
  • Based on the results of establishing the causes of deviations and inconsistencies, appropriate corrective and/or preventive measures should be developed and implemented;
  • Trainings of personnel impacted for quality of the products in accordance with training programs;
  • Ensuring that there is an agreement (contract) between the parties that defines their respective responsibilities regarding quality control checks;
  • Participating in quality risk management as a systemic process;
  • Ensuring of control of the documentation system for correctness, completeness, accessibility and comprehensibility of documents, their development, registration, approval, approval, review, removal, archiving, etc.;
  • Taking urgent measures to implement the orders of the Ministry of Health and the State Medical Service regarding the suspension of importation, withdrawal from circulation of medicinal products;
  • Participating in a self-inspection and/or quality audit procedure that regularly assesses the effectiveness and suitability of the quality system for pharmaceutical products. Performing of external quality audits;
  • Organization of the review of complaints for products, to identify cases of quality defects and to take appropriate measures both in relation to low-quality medicinal products and to prevent similar cases;
  • Performing of mock-up recalls and actual product recalls, if necessary..

Experience Required

  • Higher level pharmaceutical education
  • At least 2 years' QP experience with overall experience in Quality of 5+ years
  • Additional skills and experience in safety (pharmacovigilance) and regulatory affairs would be beneficial.
  • Fluent in English
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Confirmed 11 hours ago. Posted 30+ days ago.

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