Offers “Sanofi”

Expires soon Sanofi

Quality Specialist (CHLOE)

  • Internship
  • Kiev, UKRAINE
  • Sales

Job description



SANOFI UKRAINE, one of the leading pharmaceutical companies, announces the position of Quality Specialist / Qualified Person

KEY RESPONSIBILITIES:

·  Maintain and support the processes of incoming control and Quality Control for market batch release of pharmaceutical products as well as the quality issues detected during marketing activities;
·  Preparation and submission of applications to State Authorities;
·  Communication with State Authorities;
·  Ensure 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;
·  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);
·  Maintain and support of the warehouse/ affiliate Quality Managements System in accordance with local regulation and in compliance with Sanofi Quality Policy, Quality Directives and Standards
·  Complaints handling management process
·  Experience in passing State inspections, opening pharmaceutical warehouse,  building of  the  QMS in the company is welcomed

REQUIREMENTS:

·  University Degree  preferable in Pharmaceutics , Biology (or related field);
·  Experience & knowledge: minimum 2+ years of experience in pharmaceutical industry, quality system or related area;
·  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;
·  Driver license;
·  Leadership qualities perseverance, creativity, ability to work under stressful conditions.

COMPANY OFFERS:

·  Professional and career growth opportunities;
·  Competitive remuneration and social package;
·  Work and development in highly professional team
·  Corporate telephone, lab-top.

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

Make every future a success.
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