Micro-Sphere SA
is a private owned company, fast growing and agile CDMO. We offer high quality, flexible contract services since 1998 and have more than 25 years of recognized expertise in spray drying and capsule filling.
We have more than 55 committed employees across 7 departments and are looking for an
AS&T Senior Specialist
to join our Quality Control department.
POSITION SUMMARY
Reporting directly to the AS&T Team leader, the AS&T Specialist is responsible for ensuring that all functions within AS&T are operating in a compliant manner. The functions within AS&T include method transfer, method validation, data review, laboratory investigation support, analytical method troubleshooting and QC project support.Suggerimenti: riepiloga le caratteristiche del ruolo, cosa serve per riuscire nella posizione e spiega come si inserisce nel quadro complessivo dell'azienda.
DUTIES & RESPONSIBILITIES
o manages laboratory commodities (reagents, standards, consumables and durables), regularly checking the actual consumption to guarantee adequate stockkeeping
o collaborates in writing of the following documents:
o analytical method validation Protocols/Reports
o analytical method transfers Protocols/Reports
o performs preliminary assessment of the analytical methods related to new projects
o is directly involved, as QC SME, in new methods development
o supports QA during investigations
o collaborates in the following QC daily business activities:
o audit readiness and related activities
o laboratory daily readiness verification
o laboratory cleaning controls and interventions
o trains and supervises the work of new QC employees
KEY COMPETENCIES
o Good analytical thinking skills
o Ability to communicate effectively, both in technical and user-friendly languages
o Good attitude to teamwork and high flexibility
MINIMUM REQUIREMENTS
o Education: High School Diploma in Chemistry or related study
o Languages: Local Language (IT) and English (independent user)
o Experience: Minimum five (5) years of Analytical Method Development experience in pharmaceutical companies.
o Familiar with main QC Lab pieces of equipment (e.g. HPLC, GC, UV, laser diffraction, Karl Fischer, etc), and SWs (e.g., Chromeleon).
o Knowledge and experience of GMP regulations.