BRR QoF & Batch Disposition Quality Specialist

myGwork - LGBTQ+ Business Community; Ferentino; In loco; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

A leading global scientific company located in Ferentino is seeking a candidate for a quality assurance role. The position requires a Bachelor’s or Master’s degree in a scientific field and 1-2 years of experience in a pharmaceutical company. Responsibilities include managing quality control processes, supporting investigations, and participating in audits. Applicants should possess good English skills and be available for shift work. The company offers competitive remuneration and a collaborative work environment.

Servizi

Competitive remuneration

Annual incentive plan bonus

Healthcare

Range of employee 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 quality control and documentation for commercial batches.
• Collaborate in managing quality investigations and CAPAs.
• Support during audits and maintain compliance with quality objectives.

Conoscenze

Good English knowledge (level B1/B2)

Experience in the pharmaceutical industry

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!