Quality Specialist at Thermo Fisher Scientific

Monza, Lombardy, Italy

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

PharmaceuticalIndustries

Requirements

Diploma with validated experience or degree
Knowledge of machinery, equipment, and methodologies for the production of drugs
In-depth knowledge of GMP regulations
Knowledge of the problems related to aseptic production
Ability to use the main information systems
Consolidated experience in QA/Production in pharmaceutical companies
English language proficiency
Tidiness
Observation skills
Relational skills
Critical thinking
(Desirable) Experience in manufacturing sterile injectable drugs and oral drugs

Responsibilities

Continuously lead all aspects of the production lines of sterile forms (cleaning, mix-up, operation, defects) to ensure adherence to latest regulations and company quality standards
Assist in coordinating and leading all aspects of machinery testing and validation tasks, ensuring compliance with regulations and company quality criteria
Participate in the execution of self-audits and implementation of corrective actions in compliance with regulations and company standards
Participate in the analysis and definition of actions to remove causes of defects and complaints
Based on controls and monitoring results, propose GMP training courses suitable for production activities and participate in them as a trainer
Contribute to the creation and editing of procedures and processing sheets, verifying their usage in operations

Skills

GMP

EU GMP

US GMP

Sterile Injectables

Machinery Validation

Quality Audits

Corrective Actions

Defect Analysis

GMP Training

SOP Editing

Production Supervision

Cleanroom Procedures

PPE

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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