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For Companies At a Glance
- Tasks: Ensure compliance with GMP regulations and manage quality systems effectively.
- Company: Join Thermo Fisher Scientific, a global leader in innovative scientific solutions.
- Benefits: Enjoy competitive pay, healthcare, bonuses, and a vibrant company culture.
- Why this job: Be part of a diverse team driving quality and innovation in the pharmaceutical industry.
- Qualifications: Degree in a scientific field or relevant experience in Quality Assurance preferred.
- Other info: Opportunities for growth and development in a dynamic work environment.
The predicted salary is between 36000 - 60000 £ per year.
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
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!
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Quality Systems & Compliance Specialist II employer: Thermo Fisher Scientific Inc.
Contact Detail:
Thermo Fisher Scientific Inc. 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 during discussions.
✨Tip Number 2
Stay updated on current GMP regulations and compliance standards relevant to the pharmaceutical and biotech industries. This knowledge will not only help you in interviews but also demonstrate your commitment to the field.
✨Tip Number 3
Network with professionals already working in quality systems and compliance roles. Engaging with them on platforms like LinkedIn can provide insights into the company culture and expectations, which can be invaluable during your application process.
✨Tip Number 4
Prepare to discuss examples of how you've contributed to quality assurance or compliance in previous roles. Highlighting specific instances where you've improved processes or ensured compliance can make a strong impression.
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 keywords from the job description to demonstrate your fit for the role.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for quality assurance and compliance. Mention specific experiences where you've successfully managed change controls or CAPA processes, and how you embody the company's values of integrity, intensity, innovation, and involvement.
Highlight Relevant Skills: In your application, emphasise your skills in using tools like TrackWise and eDMS. Provide examples of how you've used these tools to support compliance and improve processes in previous roles.
Showcase Continuous Improvement Experience: Discuss any involvement in continuous improvement programs or projects. Highlight your proactive approach to problem-solving and how you've contributed to enhancing quality management systems in past positions.
How to prepare for a job interview at Thermo Fisher Scientific Inc.
✨Know Your Regulatory GMPs
Familiarise yourself with Good Manufacturing Practices (GMP) and how they apply to the role. Be prepared to discuss specific examples of how you've ensured compliance in previous positions, as this will demonstrate your understanding and commitment to quality standards.
✨Showcase Your Technical Skills
Highlight your experience with tools like TrackWise, eDMS, and SAP during the interview. Be ready to explain how you've used these systems to manage quality processes, as this will show that you can hit the ground running in the role.
✨Emphasise Team Collaboration
Since the role involves working with diverse teams, share examples of successful collaborations from your past. Discuss how you’ve contributed to team projects and how you handle challenges within a group setting to showcase your interpersonal skills.
✨Demonstrate Continuous Improvement Mindset
Be prepared to talk about your experience with continuous improvement initiatives. Share specific instances where you've identified areas for improvement and the steps you took to implement changes, aligning with the company's focus on innovation and efficiency.
