Quality Specialist II

Thermo Fisher Scientific; Swindon; On-site; GBP 30,000 - 50,000; Full time

Job summary

Ein dynamisches Unternehmen sucht einen Quality Systems & Compliance Specialist, der leidenschaftlich daran interessiert ist, das Qualitätsmanagementsystem zu verbessern und die Einhaltung globaler cGMP-Vorschriften sicherzustellen. In dieser Rolle werden Sie eine Schlüsselrolle bei der Unterstützung von Lieferanten, der Verwaltung von Abweichungen und der Durchführung von Schulungen spielen. Diese Position bietet die Möglichkeit, mit verschiedenen Funktionen innerhalb eines globalen Marktführers zusammenzuarbeiten und wertvolle Erfahrungen zu sammeln. Wenn Sie ein selbstmotivierter Problemlöser sind, der gerne in einem kollaborativen Umfeld arbeitet, ist dies die perfekte Gelegenheit für Sie.

Qualifications

• Mindestens 2 Jahre relevante pharmazeutische Erfahrung.
• Starkes Verständnis von QMS-Prozessen wie Abweichungen und SOPs.

Responsibilities

• Unterstützung bei der Einhaltung von cGMP-Vorschriften.
• Verwaltung von Abweichungen und CAPA sowie Teilnahme an Audits.

Skills

Qualitätsmanagementsysteme (QMS)

Pharmazeutische Erfahrung

Audits und Inspektionen

Änderungsmanagement

Dokumentenlebenszyklusmanagement

Risikomanagement

Kommunikationsfähigkeiten

Education

Relevanter Abschluss in Wissenschaft (Chemie, Biologie)

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Thermo Fisher Scientific and be part of a diverse, hardworking team passionate about exploration and discovery. With revenues exceeding $40 billion and the industry's largest R&D investment, we provide resources and opportunities for meaningful contributions worldwide.

The successful candidate will manage tasks related to the site's Quality Management System (QMS), ensuring compliance with regulatory and corporate standards, and maintaining the safety, efficacy, and quality of our products.

The Quality Systems & Compliance Specialist will support a dynamic team to establish and maintain inspection readiness, including ownership of key quality processes.

Responsibilities and Duties

We seek a dedicated individual passionate about improving and maintaining the QMS while ensuring compliance with global cGMP regulations.

Aligning with our 4i values—integrity, intensity, innovation, and involvement—you will adhere to GMP requirements and company policies.

Your tasks will include supporting supplier assurance, managing deviations and CAPA, participating in audits and inspections, conducting training, risk management, change control, document lifecycle management, and metrics reporting.

You will collaborate with internal and external stakeholders to monitor and achieve key targets efficiently.

This role offers exposure to various functions within the broader quality team, providing growth and diverse experiences within a global leader.

Education & Skills

· Relevant degree or equivalent experience in Science (e.g., Chemistry, Biology)

· Minimum of 2 years relevant pharmaceutical experience

· Strong understanding of QMS processes such as deviations, audits, change control, SOPs

· Well-organized, proactive, and a dynamic problem solver

· Excellent written and verbal communication skills

· Self-motivated, independent, detail-oriented, and collaborative with a strong sense of integrity and compliance