PDS Quality on the Floor Specialist

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.