Quality Specialist

SANOFI UKRAINE, one of the leading pharmaceutical companies, announces the position of Quality Specialist (one year contract).

KEY RESPONSIBILITIES:

• Support the process of Quality Control for market batch release of pharmaceutical products as well as the quality issues detected during marketing activities;
• Ensure (support Qualifies Person and Country Quality Head) that product release of the imported medicinal products performed in time and in accordance with local regulation and in compliance with Sanofi Quality Policy, Quality Directives and Standards;
• Control of preparation and submission of applications to State Authorities;
• Ensuring compliance of Certificates of Analysis (CoA) with the Ukrainian legislation and Product Registration Dossier/specification and translation support;
• Interaction with Global Quality, all relevant subdivisions and manufacturing sites of Sanofi Group concerning questions with CoAs from the Product Registration Dossier request for corrected CoAs and confirmation letters from relevant Quality contacts;
• Preparation of statements and letters during the State Quality Control to the State Authorities, Quality Control Laboratories for getting positive conclusion/ permission from State Authorities for product release by Sanofi Ukraine;
• Handling the procedure of laboratory analysis of products (sampling, documentation workflow);
• Participation in the maintenance of the affiliate Quality Managements System, with the emphasis on the following issues:
  1) Handling Quality Agreements;
  2) Handling quality events in relation to pharmaceutical products and processes;
  3) Participation in risk management process in relation to pharmaceutical products and processes.

REQUIREMENTS:

• University Degree in Pharmaceutics, Biology, Medicine (or related field);

• Experience & knowledge: 1+ years of experience in pharmaceutical industry;

• Experience in the area of quality control of pharmaceutical products;
  
• Knowledge of relevant legislation and regulatory guidelines;
• Computer literacy (PC user, MS Office);
• Upper Intermediate English, both reading and writing.

COMPANY OFFERS:

• Professional and career growth opportunities;
• Competitive remuneration and social package;
• Work and development in highly professional team.