Quality Systems

4 months ago

Swindon, United Kingdom Thermo Fisher Scientific Full time

**Job Summary**

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.

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.

**Responsibilities and Duties**:

- 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
- Previous, 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.

**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

**About us**

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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