Quality Engineer III - 1 year contract at Thermo Fisher Scientific

Groningen, Groningen, Netherlands

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biopharmaceutical, ManufacturingIndustries

Requirements

Adherence to Good Manufacturing Practices (GMP) and Safety Standards
Knowledge of international quality standards (FDA, EMEA, ICH) and cGMP regulations
Expertise in using electronic databases (e.g., Trackwise) for documenting quality-related events
Ability to communicate effectively in electronic, written, and verbal forms with departments (QC, ENG, MSAT, OPS)
Continuous development of expertise in quality assurance
Collaboration skills with QA Officers, internal/external QA professionals, and other departments
Work according to Safety, Health, and Environmental (SHE) guidelines

Responsibilities

Ensure cGMP manufacturing activities are completed according to requirements, adhering to SOPs and regulatory guidelines
Engage directly with manufacturing operations to ensure compliance, document review, and deviation handling
Support all phases of batch documentation, including initiation, authoring, approval, and mastering
Review and approve cGMP documentation
Ensure alignment of Standard Operating Procedures and documentation practices for efficient quality release of materials
Conduct incident investigations to understand root causes and prevent recurrence
Perform internal audits
Perform quality controls before line clearance and drive change-over activities
Operate under various quality oversight models based on manufacturing modes
Develop, implement, maintain, and audit Quality Systems across manufacturing on a daily basis

Skills

cGMP

GMP

FDA

EMEA

ICH

SOP

Trackwise

deviation handling

root cause analysis

batch documentation

internal audits

incident investigations

quality systems

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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