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Full-time
bachelor degree, postgraduate degree
Posted 2d ago
~40 hrs/week
Responsibilities
The Quality on the Floor Specialist is responsible for reviewing GMP batch records, performing shop floor inspections, and ensuring compliance with regulatory standards. They also collaborate with production teams to drive continuous improvement and support investigations into quality issues.
Requirements
Candidates must hold a Bachelor's or Master's degree in a relevant scientific discipline such as Pharmacy, Chemistry, or Biology. Proficiency in English and Italian, along with a strong understanding of GMP and sterile manufacturing processes, is required.
Full 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.
Related keywords
GMPQuality AssurancePharmaceutical ManufacturingBatch Record ReviewFDACleanroomSterile ManufacturingCAPARoot Cause AnalysisSOPPPISAPMES-PMXLIMSQuality CultureCompliance
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
For more information, please visit www.thermofisher.com.
Offices: 168 Third Avenue, Waltham, MA, US
Analytical InstrumentsLaboratory Supply Chain Programs and eCommerceLaboratory EquipmentLab ServicesSpecialty DiagnosticsLife SciencesPharma Servicesand CDMOElectronicsHealth Care
How many Engineering jobs are open in Monza, Italy right now?
There are currently 33 open engineering positions in Monza, Italy listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Engineering roles in Monza, Italy?
Companies currently hiring include Thermo Fisher Scientific, QVC Group, everience Italia, Alfa Laval, EY, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Engineering jobs in Monza, Italy?
Yes — 15 of the 33 open engineering positions offer remote or hybrid work (0 remote, 15 hybrid).
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