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- Tasks: Ensure compliance with GMP regulations and maintain product quality in a dynamic team environment.
- Company: Join Thermo Fisher Scientific, a global leader in innovative scientific solutions.
- Benefits: Enjoy competitive pay, healthcare, and a vibrant company culture focused on integrity and innovation.
- Why this job: Be part of a diverse team driving continuous improvement and making a real impact in the industry.
- Qualifications: A degree in a scientific field or relevant experience in Quality Assurance is preferred.
- Other info: This full-time role offers excellent career development opportunities in a supportive environment.
The predicted salary is between 30000 - 42000 ÂŁ per year.
Quality Systems & Compliance Specialist II
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Quality Systems & Compliance Specialist II
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Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Business Job Title: Quality Systems & Compliance Specialist II
Position Summary:
Join Thermo Fischer Scientific as a Quality Systems and Compliance Specialist, ensuring compliance with Regulatory GMP’s and corporate requirements, as well as the safety, efficacy and quality of the products produced.
Responsibilities
- Efficiently use available tools (e.g. TrackWise, eDMS, SFLMS, SAP), to support site success in a variety of tasks associated with QS&C responsibilities.
- As an eDMS author you will prepare GMP documents.
- As a TrackWise user you will write change controls, and own & progress CAPA and action items to completion.
- Process ownership of designated QMS process
- Support risk management, change control, supplier assurance, deviations and CAPA management, document lifecycle, internal audits, training and metrics reporting.
- Help to maintain a state of inspection readiness
- As a qualified QSME you will train others in QMS processes, assist in delivery of GMP training & on the job training which may include innovative technologies.
- Remain up to date with Corporate and regulatory cGMP requirements
- Working in coordination with internal and external customers ensure key targets and objectives are efficiently monitored and achieved.
- Participate in the continuous improvement program (PPI), supporting site wide & cross functional projects as well as departmental ones.
- 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 work with and support a diverse, innovative team to implement and maintain effective QMS processes and compliance across the site.
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
- Degree within a scientific subject or equivalent is preferable, although demonstration of suitable experience in a regulated industry (ideally within Quality Assurance) could be acceptable.
- Experience of working within the pharmaceutical/ biotech/ medical device industry would be advantageous.
- A strong quality attitude with tenacious attention to detail and proven degree of accuracy
- A strong understanding of process ownership
- Well organised, proactive with a dynamic approach to problem solving, challenging assignments & working to critical timelines
- Excellent interpersonal written & verbal communication skills
- Independent worker but also a phenomenal teammate
- Collaborative style, good sense of integrity and compliance
- Numerate and literate with analytical capabilities
Benefits
We offer competitive remuneration, attractive shift allowance, 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!
Seniority level
-
Seniority level
Not Applicable
Employment type
-
Employment type
Full-time
Job function
-
Job function
Quality Assurance, Product Management, and Engineering
-
Industries
Pharmaceutical Manufacturing and Biotechnology Research
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Quality Systems & Compliance Specialist II employer: Thermo Fisher Scientific
Contact Detail:
Thermo Fisher Scientific Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Systems & Compliance Specialist II
✨Tip Number 1
Familiarise yourself with the specific tools mentioned in the job description, such as TrackWise and eDMS. Having hands-on experience or even a basic understanding of these systems can set you apart from other candidates.
✨Tip Number 2
Network with professionals in the pharmaceutical and biotech industries. Attend relevant events or join online forums to connect with individuals who may have insights into Thermo Fisher Scientific's work culture and expectations.
✨Tip Number 3
Stay updated on current cGMP regulations and industry standards. Demonstrating your knowledge of compliance and quality assurance practices during interviews can showcase your commitment to the role.
✨Tip Number 4
Prepare to discuss your problem-solving skills and how you've handled challenging situations in previous roles. Providing concrete examples will help illustrate your proactive approach and ability to work under pressure.
We think you need these skills to ace Quality Systems & Compliance Specialist II
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in quality systems and compliance, particularly within the pharmaceutical or biotech industries. Use specific examples that demonstrate your attention to detail and understanding of GMP requirements.
Craft a Strong Cover Letter: In your cover letter, express your passion for quality assurance and compliance. Mention how your skills align with Thermo Fisher Scientific's values of integrity, intensity, innovation, and involvement. Be sure to include any experience with tools like TrackWise or eDMS.
Showcase Relevant Skills: Highlight your organisational skills and problem-solving abilities in your application. Provide examples of how you've successfully managed change controls or CAPA processes in previous roles, as these are key responsibilities for the position.
Proofread Your Application: Before submitting, carefully proofread your application materials. Ensure there are no spelling or grammatical errors, as this reflects your attention to detail—an essential trait for a Quality Systems & Compliance Specialist.
How to prepare for a job interview at Thermo Fisher Scientific
✨Know Your Quality Systems
Familiarise yourself with the specific quality systems and compliance tools mentioned in the job description, such as TrackWise and eDMS. Be prepared to discuss your experience with these tools and how you've used them to ensure compliance in previous roles.
✨Demonstrate Attention to Detail
Given the emphasis on accuracy and a strong quality attitude, be ready to provide examples of how your attention to detail has positively impacted your work. This could include instances where you identified errors or improved processes.
✨Showcase Your Problem-Solving Skills
Prepare to discuss specific challenges you've faced in a regulated environment and how you approached solving them. Highlight your proactive and dynamic approach to problem-solving, especially under critical timelines.
✨Embody the Company Values
Thermo Fisher Scientific values integrity, intensity, innovation, and involvement. Think of examples from your past experiences that demonstrate how you embody these values, and be ready to share them during the interview.
