PDS Quality on the Floor

JOB DESCRIPTION

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, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

DESCRIPTION:

Thermo Fisher Scientific, the world leader in serving science, is seeking a Quality on the Floor Specialist to join its PDS business unit.

Key Responsibilities

Batch Record Review

• Review relevant GMP batch records (including human and veterinary products, as well as batches intended to generate GMP-related data, such as Media Fill, engineering batches for characterization, stability studies, or regulatory submissions).
• Verify compliance with product specifications, company procedures, and applicable regulatory requirements, documenting the review through the designated checklist.

Customer Support

• Provide support to customers on matters within the area of expertise.
• Liaise directly with customers to address questions related to batch record review, ensuring the proper release and management of relevant GMP batches.

Production Floor Oversight

• Perform routine shop floor inspections and promote a proactive Quality Culture throughout the manufacturing areas.
• Encourage the sharing of issues and related corrective actions with Production through regular huddle meetings.
• Support the Quality Systems & Compliance team in conducting periodic Fit & Finish assessments and Quality Oversight activities.

Continuous Improvement

• Collaborate with the Production Department and the Practical Process Improvement (PPI) team to drive continuous improvement initiatives.
• Support the implementation of new workflows, optimization of procedures, and development of PPI tools.

Training & Procedures

• Deliver training to personnel involved in Quality on the Floor activities and to Manufacturing personnel on topics related to the area of responsibility, in accordance with company procedures.
• Support the Team Leader in updating Standard Operating Procedures (SOPs) by preparing the required documentation based on business needs and current GMP requirements.

Production Investigations

• Collaborate with the Quality Operations team and Manufacturing Quality Specialists to ensure the effective execution of investigations.
• Support root cause analysis and contribute to the identification of appropriate corrective and preventive actions (CAPAs), in compliance with company quality standards and applicable regulations.

Master Batch Records (MBR)

• When required, collaborate with the Master Batch Record function to provide and authorize the distribution of controlled copies of Master Batch Records.

Quality & Compliance

• Perform all activities in accordance with company quality standards, policies, and procedures, ensuring compliance with applicable regulations, including GMP, FDA, and other relevant requirements.

Qualifications & Experience

• Bachelor's or Master's degree in Pharmaceutical Chemistry and Technology (CTF), Pharmacy, Chemistry, Biology, or another relevant scientific discipline, or equivalent demonstrated experience.
• Knowledge of sterile pharmaceutical manufacturing processes and production controls.
• Good understanding of GMP and FDA regulations.
• Proficiency in both English and Italian.
• Excellent interpersonal and communication skills.
• Proactive mindset with a strong sense of ownership.
• Ability to work effectively in a cross-functional team environment.
• Familiarity with enterprise systems such as SAP, MES-PMX, and LIMS, as well as Microsoft Office applications, is considered an advantage.