BRR QoF & Batch Disposition Quality Specialist - Fixed Term Contract

myGwork - LGBTQ+ Business Community; Ferentino; In loco; EUR 30.000 - 45.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical company located in Ferentino, Italy is seeking a Quality Specialist to perform batch release processes and ensure compliance with quality standards. The ideal candidate will hold a Bachelor's or Master's degree in a scientific field and have 1-2 years of experience in the quality department. The role requires good English proficiency and availability to work across shifts. Join a dynamic team dedicated to impactful work and continuous improvement.

Servizi

Competitive remuneration

Annual incentive plan bonus

Healthcare benefits

Competenze

• 1-2 years of experience in a pharmaceutical company, ideally in the Quality department.
• Availability to work on shifts (Monday-Friday, mornings and afternoons).

Mansioni

• Perform batch release and prepare documents for quality approval.
• Train personnel involved in quality activities.
• Support investigation team in quality issue handling.

Conoscenze

Quality assurance

Statistical analysis

Good English knowledge

Training and development

Formazione

Bachelor's or Master's Degree in Scientific field

Descrizione del lavoro

Job Description

At Thermo Fisher Scientific team, 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, with the largest investment in R&D in the industry, 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.

Location/Division Specific Information

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

Specific Tasks And 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 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!