Quality Systems Specialist

4 days ago

Swindon, United Kingdom Thermo Fisher Scientific Full time

When you are part of Thermo Fisher Scientific, you will do meaningful work, and be part of a team that values performance, quality and innovation. As a member of a successful, growing global organization you will be encouraged to perform at your best. With revenues of $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

**Location/Division Specific Information**

The role is based at the Swindon, UK site.

**How will you make an impact?**
The Quality Systems team ensures that systems used on site such as Documentation Control and Management, Deviations, CAPA and Change Control; are in place, robust and effective. This ensures no adverse impact to operations, product and systems.

The Quality Systems Specialist will work with and support the team to implement and maintain effective Quality systems across the site. This will ensure that the products we produce are safe and efficacious for our patients.

**What will you do?**
- Ensure alignment of the Deviation and CAPA processes with corporate expectations
- Collaborate with internal customers to ensure systems are fully understood and embedded
- Drive improvements and optimisation of quality system(s) using continuous improvement tools
- Prepare & deliver vocational training in aligned systems
- Write, simplify, and prepare GMP documents
- Ensure Key Performance Indicators, plans, targets and objectives are successfully met and completed on time
- Monitor site performance and provide input into governance forums to demonstrate compliance with and efficiency of the systems
- Cross train in other Quality Systems processes to support team members.
- Follow GMP requirements, company rules, policies, and procedures.
- Ensure compliance with environment, Health and Safety requirements at all times.
- Ensure timely reporting and investigation of all accidents, near misses and breaches of rules.

**Knowledge, Skills, and Requirements**:

- A science-based degree, e.g., Chemistry, Biology, Pharmacy, Pharmaceutical Sciences or equivalent
- Experience of working in a Pharmaceutical/ biotech/ medical device industry
- Demonstrated experience of managing a Quality Management System e.g., Deviations, CAPA, Change Control
- Excellent understanding of the principles and guidelines of cGMP.
- Must be a self-starter who can take general concepts and direction and produce desirable results.
- Ability to effectively communicate, both verbal and written, with internal and external customers.
- Ability to work in cross-functional teams and effectively interact with all levels in the company.
- Ability to function in a dynamic environment and balance multiple priorities simultaneously.
- Ability to organise time, plan and prioritise work effectively

**Physical Demands**:

- While performing the duties of this job, the employee may be required to write, read/review written documentation for extended periods of time.

**What is in it for you?**
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 enthusiastic 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.

You'll also receive a salary reflective of your experience, company bonus scheme, private medical insurance, life assurance, contributory pension, with the option to tailor additional benefits to suit you

Our Mission is to enable our customers to make the world healthier, cleaner and safer.

Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation, and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific.

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