Shire Process Validation Specialist in Rieti (Baxalta), Italy
Understand process criticalities and develop and execute validation documents as appropriate in compliance with responsible instructions, main internal and external guidelines and policies, assuring Validation activities plan completion.
Support the team leader and his/her team colleagues ensuring the validation of business processes, writing protocols, executing validation activities and writing validation reports, in compliance with cGMP, Clients’ needs and the Company's quality standards.
Participate in process risk assessment development and technical failure analysis of processes/systems. Manage deadlines, change control activities related to the production process, systems, products as assigned. Guarantee communications with Customers and Interfaces for the assigned duties and items
Participate in continuous improvement and global standardization initiatives and communities within the organization
BS Degree or equivalent in Engineering, Chemistry, Life Science, or other job related discipline
Knowledge of pharmaceutical processes and the main analytical methods;
Fluent English (written and spoken);
Proficiency in Microsoft Office
At least 3 years of previous experience in this role or equivalent within pharmaceutical, biotechnology, or related industry, familiar with Quality Management and GxP Regulations
Project management experience
Lean /6-σ certifications
Knowledge of software for statistical analysis;
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.