PDS Quality on the floor

ThermoFisher Scientific; Monza; On-site; EUR 60,000 - 80,000; Full time

Job summary

Thermo Fisher Scientific in Lombardia seeks a Lead QA Technician to ensure product quality and regulatory compliance in pharmaceutical manufacturing. You will oversee quality systems, CAPA programs, batch records and deviations, and support regulatory inspections while collaborating with cross-functional teams to drive continuous improvement.

You have strong GMP knowledge, experience with TrackWise/Documentum, aseptic processing, and excellent communication skills to guide and develop team

Qualifications

• 4 years of experience in pharmaceutical quality assurance or GMP environment.
• Knowledge of GMP regulations, FDA guidelines and quality systems.
• Experience with batch records, deviations and CAPA management.

Responsibilities

• Ensure product quality and regulatory compliance in pharmaceutical manufacturing.
• Provide quality oversight and support for production operations.
• Assist in regulatory inspections and customer audits.
• Maintain and improve quality documentation systems and processes.
• Guide and develop team members and coordinate cross-functional activities.

Skills

Quality assurance

GMP compliance

CAPA management

Batch record review

Deviation investigations

Aseptic processing

Cross-functional teamwork

Regulatory inspections support

Root cause analysis

Quality documentation

Education

Bachelor's in Chemistry

Bachelor's in Pharmacy

Biotechnology

Life sciences

Tools

TrackWise

Documentum

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, Standing for full shift

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:

Join Thermo Fisher Scientific as a Lead QA Technician and contribute to ensuring product quality and regulatory compliance. As a member of our Quality team, you'll help enable our mission of making the world healthier, cleaner and safer through quality oversight of pharmaceutical manufacturing operations. Your expertise will help maintain high standards of quality while supporting production of life-changing medicines.

REQUIREMENTS:

• 4 years of experience in pharmaceutical quality assurance or related GMP environment
• Preferred Fields of Study: Chemistry, Pharmacy, Biology, Biotechnology or related scientific field
• Comprehensive knowledge of GMP regulations, FDA guidelines and quality systems
• Expertise in batch record review, deviation investigations and CAPA management
• Strong understanding of aseptic manufacturing processes and controls
• Advanced proficiency in quality documentation systems (e.g. TrackWise, Documentum)
• Professional communication skills both written and spoken
• Ability to manage multiple priorities in a dynamic environment
• Strong attention to detail and analytical problem-solving skills
• Effective interpersonal and communication abilities
• Project management and organizational capabilities
• Experience supporting regulatory inspections and customer audits
• Demonstrated ability to work effectively with cross-functional teams
• Proficiency with Microsoft Office applications
• Ability to work various shifts as required
• Knowledge of root cause analysis and quality improvement tools
• Demonstrated ability to guide and develop team members
• Experience with clean room operations and gowning procedures preferred
• Ability to understand and interpret technical procedures and specifications

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.