BRR QoF & Batch Disposition Quality Specialist

Thermo Fisher Scientific; Ferentino; In loco; EUR 35.000 - 50.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical company in Ferentino seeks a BRR QoF & Batch Disposition Quality Specialist to ensure quality assurance and compliance processes for clinical and commercial product batches. The ideal candidate has a degree in a scientific field and 1-2 years of relevant experience. Responsibilities include batch release, statistical analyses, and staff training. A competitive remuneration package along with health benefits is offered.

Servizi

Competitive remuneration

Annual incentive plan bonus

Healthcare

Career development prospects

Competenze

• Degree in a Scientific field required.
• 1-2 years experience in pharmaceutical quality control.
• Good English communication skills (B1/B2).

Mansioni

• Perform batch release and documentation.
• Conduct statistical control activities.
• Train staff involved in quality activities.
• Support quality investigations and CAPAs management.

Conoscenze

Quality Control

Statistical Analysis

Training

Root Cause Analysis

Customer Communication

Formazione

Bachelor's or Master's Degree in Science

Descrizione del lavoro

BRR QoF & Batch Disposition Quality Specialist

Join to apply for the BRR QoF & Batch Disposition Quality Specialist role at Thermo Fisher Scientific.

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

Work Schedule: Standard (Mon-Fri)

Environmental Conditions: Office

Overview

At Thermo Fisher Scientific you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons—with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building an exciting career with us.

Responsibilities

• We perform the Batch of the commercial batches manufactured and prepare the release documents to be submitted for approval by the QP.
• We perform Statistical Control (AQL) activities downstream of the inspection for products manufactured in the DPS & PDS area.
• Trains the personnel involved in quality activities.
• Supports the investigation team in handling quality issues of batches manufactured for clinical and commercial use, by identifying corrective and preventive actions.
• We collaborate CAPAs management resulting from quality investigations, verifying their efficiency over time.
• Supports and actively participates in initiatives/projects in the area of Operational Excellence.
• Actively join all meetings established for new and ongoing projects.
• We collaborate in coordinating technical and management meetings with customers.
• Supports during clients/quality inspections (Audit) and internal and regulatory body quality inspections.
• We generate reports on quality events.
• We support the achievement of quality objectives for the part the job competence, and of the RFT, Deviation Rate, Past due, Ontime closure objectives.
• We collaborate with Compliance colleagues in the quality system SOPs review that fall within the scope of the Quality Unit to which belongs.
• We provide support to customers via TLC and email, promptly responding to quality questions.
• Collaborates in the drafting of FMEAs.
• Deals with the drafting, archiving, distribution of controlled company documentation.
• Within the PDS organization, carries out document issuing activities to support Production/PPT/Quality System colleagues.
• Actively drafts 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.
• Supports the team and other functions in ensuring full support for Readiness and BUs processes.

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).

Physical Requirements / Work Environment

Work in a dynamic, collaborative setting, managing several tasks and projects with strict compliance and quality focus.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Employer Details

• Seniority level: Not Applicable
• Employment type: Full-time
• Job function: Quality Assurance, Product Management, and Engineering
• Industries: Pharmaceutical Manufacturing and Biotechnology Research