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
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
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
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:
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.