Quality Systems & Compliance Specialist

Position Location:Swindon

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving sophisticated analytical challenges, improving patient diagnostics and therapies or growing efficiency in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an outstanding combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com

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.

In this role, the successful applicant will undertake multifaceted tasks across the site’s Quality Management System (QMS), ensuring compliance with both European and U.S. GMP’s and corporate requirements, as well as the safety, efficacy and quality of the products produced.

The Quality Systems & Compliance Specialist will work with and support a diverse, innovative team to implement and maintain effective QMS processes and compliance across the site, providing assurance that quality product is manufactured, tested, and released to patients.

The team leads the QMS processes to maintain a state of inspection readiness including the management of key quality processes.

• We are looking for a dedicated, resourceful Quality minded individual with up-to-date knowledge, and passion for driving and sustaining improvements to the QMS to ensure compliance to UK, EU & FDA cGMP regulations.
• The applicant will efficiently use all of the available electronic tools (e.g. Trackwise, eDMS, SFLMS), to support site success in a variety of tasks associated with Quality systems and compliance responsibilities.
• Whilst embodying the companies 4i values of integrity, intensity, innovation, and involvement you will align with GMP requirements and company rules, policies, and procedures.
• As a member of the QS & C team each day could be different as you undertake a varied range of activities to support risk management, change control, supplier assurance, deviations and CAPA management, document lifecycle, internal audits, and metrics reporting. This will require you staying up to date with corporate requirements, standard process and regulatory rules and regulations.
• You will qualify as a QSME to assist with the delivery of GMP training & on the job training which may include innovative technologies.
• As an eDMS author you will prepare GMP documents. Additionally, as a TrackWise user you will write minor and major deviation investigations, change controls, and handle audits within GTW.
• Working in coordination with internal and external customers will ensure key targets and objectives are efficiently monitored and achieved.
• With a natural drive for improvement & optimisation of processes you will participate in the continuous improvement program (PPI), supporting site wide & cross functional projects as well as departmental ones.
• In order to support the quality organisation you will step up for other QA and Compliance related tasks where required.
• As an advocate for EHS you will ensure compliance with environment, health and safety rules, timely reporting of any accidents & near misses.
• 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 self-motivated and passionate individual, there really is no limit to the growth and experience on offer and as a global leader, we can offer you all sorts of opportunity.

Education & Skills

• Relevant science based degree; e.g. Chemistry, Biology.
• A minimum of 2 years relevant pharmaceutical experience.
• A strong understanding of cGMP & basic QMS e.g. deviations, change control, SOPs.
• Well organised, proactive with a dynamic approach to problem solving, challenging assignments & working to critical timelines.
• 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.
• Auditing experience and use of electronic QMS systems (e.,g TrackWise would be preferred.

At Thermo Fisher Scientific, each one of our 110,000 outstanding minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

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