BRR QoF & Batch Disposition Quality Specialist at Thermo Fisher Scientific

Ferentino, Latium, Italy

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Life Sciences, PharmaceuticalsIndustries

Requirements

Bachelor's or Master's Degree in Scientific field
One or two years of experience in a pharmaceutical company, ideally in the Quality department
Good English knowledge (level B1/B2)
Availability to work on shifts (Monday-Friday, mornings and afternoons)

Responsibilities

Perform the Batch Review Record (BRR) of commercial batches manufactured and prepare release documents for approval by the QP
Perform Statistical Control (AQL) activities downstream of the inspection for products manufactured in the DPS & PDS area
Train personnel involved in quality activities
Support the investigation team in handling quality issues of batches manufactured for clinical and commercial use, by identifying corrective and preventive actions
Collaborate in CAPA management resulting from quality investigations, verifying their efficiency over time
Support and actively participate in initiatives/projects in the area of Operational Excellence
Actively join all meetings established for new and ongoing projects
Collaborate in coordinating technical and management meetings with customers
Support during clients/quality inspections (Audit) and internal and regulatory body quality inspections
Generate reports on quality events
Support the achievement of quality objectives within job competence, and of RFT, Deviation Rate, Past due, Ontime closure objectives
Collaborate with Compliance colleagues in the review of Quality System SOPs that fall within the scope of the Quality Unit
Provide support to customers via telephone and email, promptly responding to quality questions
Collaborate in the drafting of FMEAs
Deal with the drafting, archiving, distribution of controlled company documentation
Within the PDS organization, carry out document issuing activities to support Production/PPT/Quality System colleagues
Actively draft QATs and review them with Customers and site QPs
Join initiatives in the PPI area (Kaizen and Gemba) supporting the continuous improvement of the site
Support the team and other functions in ensuring full support for Readiness and BUs processes

Skills

Key technologies and capabilities for this role

Batch Record ReviewBatch DispositionAQLStatistical ControlCAPA ManagementQuality InvestigationsQP ReleaseAudit SupportPersonnel TrainingOperational Excellence

Questions & Answers

Common questions about this position

What is the location for this position?

This position is located in Ferentino, Province of Frosinone, Italy.

What education is required for this role?

A Bachelor's or Master's Degree in a Scientific field is required.

What experience is needed for this position?

One or two years of experience is required.

What is the work schedule for this job?

The work schedule is standard Monday through Friday in an office environment.

What does the company culture emphasize?

The culture is dedicated to impactful work, innovative thinking, working the right way with the customer top of mind, and empowering colleagues to realize their full potential in a fast-growing global organization.

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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