Quality Specialist II

The successful applicant will handle various tasks related to the site's Quality Management System (QMS). They will help to ensure compliance with regulatory & corporate requirements, and uphold the safety, efficacy, and quality of the products produced at the site.

The Quality Systems & Compliance Specialist will support a diverse and innovative team to establish and uphold a state of inspection readiness including the ownership of key quality processes.

Responsibilities and Duties

Seeking a dedicated and resourceful individual, passionate about driving and sustaining improvements to the QMS, whilst ensuring compliance with global cGMP regulations.

Whilst embodying the companies 4i values of integrity, intensity, innovation, and involvement you will align with GMP requirements and company rules, policies, and procedures.

You will have a diverse range of tasks as a member of the QS&C team. These include supporting supplier assurance, deviations and CAPA management, audits and inspections, training, risk management, change control, document lifecycle, and metrics reporting.

Collaborating with internal and external customers will ensure key targets and objectives are efficiently monitored and achieved.

This is a diverse role, with the opportunity to gain exposure to a wide range of different functions within the wider quality team. As a global leader we offer endless growth and experience to self-motivated individuals.

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

· A minimum of 2 years relevant pharmaceutical experience.

· A strong understanding of QMS processes e.g. deviations, audits, change control, SOPs.

· Well organised, proactive with a dynamic approach to problem solving!

· Excellent interpersonal written & verbal communication skills.

· Able to work with a high degree of self-motivation and independence with attention to detail,

· Collaborative style, good sense of integrity and compliance

When you join us at Thermo Fisher Scientific, you'll be surrounded by a diverse, hard working, team that shares your passion for exploration and discovery. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our colleagues the resources and opportunities to make meaningful contributions to the world.