Job Information
ThermoFisher Scientific PDS Quality on the Floor Specialist in Monza, Italy
Work Schedule
Rotational shift nights/weekends
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed
Job Description
Quality on the Floor Specialist
Thermo Fisher Scientific, world leader in serving Science, is seeking a Quality on the Floor Specialist for the PDS Business Unit .
Key Responsibilities
Perform GMP Batch Record Review for manufacturing, media fill and engineering batches, ensuring compliance with specifications, procedures and regulatory requirements.
Provide QA support for customer-related batch review activities , ensuring correct and timely batch release.
Execute on-the-floor QA oversight of production activities and promote Quality Culture within manufacturing areas.
Support continuous improvement initiatives in collaboration with Production and PPI teams.
Deliver training and support SOP updates in accordance with GMP requirements.
Support investigations and CAPA activities in collaboration with Quality Operations and departmental Quality teams.
Support Master Batch Record (MBR) activities, when required.
Ensure compliance with company quality standards and applicable regulations (GMP, FDA).
Requirements & Qualifications
Degree in Pharmacy, Pharmaceutical Chemistry and Technology, Chemistry, Biology or equivalent scientific background, or proven relevant experience.
Knowledge of sterile pharmaceutical manufacturing and GMP/FDA regulations .
Fluency in Italian and English .
Strong communication skills and ability to work in a team.
Knowledge of SAP, MES-PMX, LIMS and Microsoft Office is a plus.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.