Shire Senior Quality Associate in Remote, Russia

This is to replace the Main Employee for the maternity leave period.

Ensure consistent approach regarding application of cGMP (current good manufacturing practice), Shire and other regulatory quality standards at Contract Manufacturing Organization (CMO).

Responsibility to check all quality aspects during the production of Shire products in cooperation with CMO such as:

  • Participation in external release activities, such as Batch Record Review

  • Operating on shop floor

  • Control of production performance and respective documentation

  • Continuous education in GMP guidelines and quality systems

  • Review and approval of quality relevant documents (e.g. specification,SOP, MBR)

  • Checking of defined critical process steps during production

  • Support of APR/PQR material preparation

  • Participation on evaluation, investigation and approval of deviations

  • Classification, approval and release of change controls

  • Checking implementation and maintenance of quality systems in CMO manufacturing facility

  • Support from Quality with technological transfer of aseptic production

Support of training / development of CMO personals

Education:

  • University or master degree education (chemistry, pharmacy, biotechnology, chemical engineering, natural science)

  • Lower education such as technical high school with pharmaceutical / chemical background combined with 3+ Y experience in Quality Assurance in Pharmaceutical industry

Professional experience:

  • Work experience in pharmaceutical industry or other industry with GMP standards or Quality system (ideally both European and Russian)

  • Knowledge of GMP guidelines and/or Quality systems (ideally both European and Russian)

  • Ideal candidate should have experience from Manufacturing and Quality Assurance departments

Special skills:

  • Team work ability

  • Good communication skills

  • Managing and organization ability

  • Conscientiousness and accuracy

  • Analytical thought (critical and objective)

  • Practice in use of computer (Word, Excel) Language skills:

  • Russian (fluent)

  • English (upper-intermediate)

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.