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- Tasks: Ensure compliance with quality systems and regulatory requirements in a dynamic office 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 quality and compliance in the pharmaceutical industry.
- Qualifications: A degree in a scientific field or relevant experience in quality assurance is preferred.
- Other info: This role offers significant growth opportunities and involvement in exciting projects.
The predicted salary is between 36000 - 60000 £ per year.
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Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Business Job Title: Quality Systems Officer
Position Summary:
Join Thermo Fischer Scientific as a Quality Systems and Compliance Officer, 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 Quality systems and compliance 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.
- 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.
The Quality Systems & Compliance Officer 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 helpful.
- A strong quality attitude with tenacious attention to detail and proven degree of accuracy
- A strong understanding of cGMP & basic QMS e.g. deviations, change control, SOPs.
- An understanding of the expectations of GMP/ DI with respect to GMP records
- 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 Officer 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 Officer
✨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 work at Thermo Fisher Scientific or similar companies, as they may provide valuable insights or referrals.
✨Tip Number 3
Stay updated on current cGMP regulations and quality management systems. Demonstrating your knowledge of the latest compliance standards during interviews can show your commitment to the role and the industry.
✨Tip Number 4
Prepare to discuss your problem-solving skills and how you've handled challenging situations in previous roles. Use specific examples that highlight your attention to detail and ability to work under pressure, as these are crucial for the Quality Systems & Compliance Officer position.
We think you need these skills to ace Quality Systems & Compliance Officer
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 understanding of cGMP and QMS processes.
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 specific tools you have experience with, such as TrackWise or eDMS.
Showcase Relevant Skills: Highlight your attention to detail, problem-solving abilities, and experience with regulatory compliance. Provide examples of how you've successfully managed change controls or CAPA processes in previous roles.
Proofread Your Application: Before submitting, carefully proofread your application materials. Ensure there are no spelling or grammatical errors, as these can detract from your professionalism. A clean, well-organised application reflects your attention to detail.
How to prepare for a job interview at Thermo Fisher Scientific
✨Know Your GMPs
Familiarise yourself with Good Manufacturing Practices (GMPs) 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 Tools Proficiency
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 how you've successfully collaborated with others in past roles. This will illustrate your ability to work well within a team and contribute to a positive work environment.
✨Prepare for Scenario Questions
Anticipate questions that may ask how you would handle specific compliance scenarios or challenges. Practising your responses to these types of questions will help you articulate your problem-solving skills and proactive approach effectively.
