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

Job Description
Thermo Fisher Scientific, a world leader in serving science, is looking for a Quality on the Floor Specialist for its PDS business unit.

SPECIFIC DUTIES/PRIMARY ACTIVITIES:

Batch Record Review

• Performs the review of relevant GMP batches (whether for human/veterinary use or intended to generate GMP-related information, e.g., MediaFill, engineering batches for characterization, stability, or registration) and verifies their compliance with specifications, company procedures, and current regulations using the appropriate checklist.

Client Support

• Provides support to clients on issues related to their area of expertise, directly interfacing with them to resolve queries related to the review, to ensure the correct release and proper management of relevant GMP batches.

Periodic Surveillance in the Production Department

• Conducts periodic surveillance of production activities and promotes Quality Culture by proactively spreading it within the departments.
• Encourages sharing of issues and related corrective actions with the Production Department through periodic huddles.
• Supports the Quality System & Compliance team in performing periodic Fit & Finish and Oversight activities.

Continuous Improvement

• Participates, in collaboration with the Production Department and the PPI Team, in the continuous improvement of the department, providing support in the implementation of new workflows, optimization of procedures, or creation of PPI Tools.

Training & Procedure

• Trains personnel involved in Quality on the Floor activities and those operating in the departments on activities related to their area of expertise, in accordance with current company procedures. Supports the Team Leader in updating SOPs related to the area of expertise by drafting the necessary documentation, based on needs and in compliance with current GMP requirements.

Departmental Investigations

• Collaborates with the Quality Operations function and Department Quality Specialists to ensure proper execution of investigations, providing support for understanding causes and participating in the identification of the most appropriate corrective or preventive actions, in accordance with company quality standards and current regulations.

MBR

• If necessary and in collaboration with the Master Batch Record function, provides and authorizes the distribution of compliant copies of MBRs.

Quality

• Operates in compliance with company quality standards, through the application of procedures related to their area of expertise, in compliance with company quality policies and procedures and in accordance with current regulations (laws, GMP standards, FDA, etc.).

REQUIREMENTS AND QUALIFICATIONS:

• Degree in CTF, Pharmacy, Chemistry, Biology, or similar scientific degrees or proven experience
• Knowledge of the production and control of sterile pharmaceutical products
• Knowledge of GMP/FDA regulations
• English, Italian
• Excellent interpersonal skills
• Proactivity
• Ability to work in a team
• Knowledge of main company IT systems (SAP, MES-PMX, LIMS) and Microsoft Office tools (desirable)