Shire PKC Lead in Rieti (Baxalta), Italy
The PKC (Process Knowledge & Control) Lead, part of the PDTS (Process Development and Technical Services) organization, is responsible for executing Process Knowledge & Control activities in order to contribute to support manufacturing operations in their Life Cycle Management activities on manufacturing processes for phase III (Continued Process Verification - CPV) and commercial products.
He/She is in close contact with the Manufacturing/Quality organizations, with relevant process experts and with Global teams representatives. Key in this role is the development of robust monitoring plans that drive to becoming more pro-active. She/he will be responsible for:
Setup and maintenance of appropriate local monitoring system of in-process parameters and quality attributes for process monitoring, according to Global indications
Implementation and maintenance of site monitoring plans
Support and active participation in definition and implementation of Global initiatives concerning the PKC activities (Monitoring&Trending Harmonization, Process Knowledge System design, Yields monitoring Harmonization)
Support for local implementation and improvement of software for monitoring (Discoverant)
Compliance to cGMP’s, GDP’s, defining, implementing and maintaining appropriate SOP’s and training
Required skills and competencies:
Broad knowledge and experience within the GMP environment, Lean and SixSigma
High level of customer orientation and organizational skills
Flexible in mind / out of the box thinker, inclination to team work
Enthusiastic, motivating and convincing personality
Good knowledge of informatic tools
Good communication skills, verbal and written
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.