At a Glance
- Tasks: Ensure compliance with quality standards and improve clinical services through data analysis.
- Company: ProPharma, a leader in biotech and pharmaceutical consulting.
- Benefits: Competitive salary, professional development, and a supportive work environment.
- Other info: Join a dynamic team dedicated to advancing scientific breakthroughs.
- Why this job: Make a real difference in patient health by enhancing quality in clinical research.
- Qualifications: Degree in relevant field and 2 years of Quality Assurance experience.
The predicted salary is between 37000 - 45000 € per year.
For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.
The Quality Specialist position supports the delivery of Clinical services, to assure ongoing compliance with quality and industry regulatory requirements. The Quality Specialist performs improvement activities through continuous monitoring and evaluation of the quality system to ensure ongoing maintenance. This position may also support regional and global activities as required.
Main Responsibilities- Generates and prepares reports to communicate outcomes of quality activities.
- Analyzes and investigates Deviations and Quality Events to identify areas for improvement in the quality system.
- Reviews, approves, and communicates root cause and corrective action to stakeholders.
- Develops, recommends, and monitors corrective and preventive actions.
- Tracks documentation, as necessary.
- Collection, management, and analysis of data related to CAPAs, Deviations and quality KPIs.
- Records, tracks, and trends audit findings and response times.
- Supports external client audits or regulatory inspections by creating reports, gathering documents, and supplying requested data.
- Performs effectiveness checks on Deviations and Quality Events to determine efficacy of CAPAs.
- Supports and facilitates eQMS activities (i.e., Document Management, QA review and approvals, Change Control assessments).
- Maintains awareness of and ensures compliance with the Good Pharmacovigilance Practices (GVP), Good Clinical Practices (GCP) requirements, and Good Documentation Practices (GDP).
- Works in a professional manner with clients, team members and management.
- Excellent computer skills including Microsoft Word and Excel.
- Analytical skills to gather and interpret data.
- Must be able to identify trends and outliers.
- Excellent written and verbal communication skills in providing feedback and identifying improvements where needed.
- Ability to prioritize and organize the tracking of data, documentation maintenance and record keeping.
- Excellent accuracy and attention to detail to ensure all products and services meet standard requirements.
- Proactive with the ability to work with minimal supervision.
- University/bachelor's degree and/or appropriate relevant work experience.
- Minimum 2 years of experience working in a Quality Assurance role.
- Deviation, CAPA, Effectiveness Check handling experience.
- Preferred: Knowledge and experience in working with GxP Quality Management Systems including but not limited to record management, reporting, and data analytics.
We are an Equal Opportunity Employer.
Clinical Quality Specialist in London employer: ProPharma
ProPharma is an exceptional employer that prioritises the health and wellness of patients while fostering a collaborative and innovative work environment. As a Clinical Quality Specialist, you will benefit from a culture that values continuous improvement and professional development, with opportunities to engage in meaningful projects that directly impact patient care. Located in a dynamic industry, ProPharma offers competitive benefits and a supportive atmosphere that encourages growth and excellence in quality assurance.
StudySmarter Expert Advice🤫
We think this is how you could land Clinical Quality Specialist in London
✨Tip Number 1
Network like a pro! Reach out to professionals in the clinical quality field on LinkedIn or at industry events. We can’t stress enough how personal connections can lead to job opportunities that aren’t even advertised.
✨Tip Number 2
Prepare for interviews by researching ProPharma and understanding their approach to quality assurance. We recommend practising common interview questions related to CAPAs and quality systems so you can showcase your expertise confidently.
✨Tip Number 3
Follow up after interviews! A quick thank-you email can set you apart from other candidates. We suggest mentioning something specific from your conversation to remind them of your fit for the Clinical Quality Specialist role.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, we often have exclusive roles listed there that you won’t find anywhere else.
We think you need these skills to ace Clinical Quality Specialist in London
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Clinical Quality Specialist role. Highlight your experience in quality assurance and any relevant skills that match the job description. We want to see how you can bring value to our team!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about quality assurance and how your background aligns with our mission at ProPharma. Keep it engaging and personal, so we get a sense of who you are.
Showcase Your Analytical Skills:Since the role involves data analysis and trend identification, make sure to include examples of how you've successfully used these skills in past roles. We love seeing concrete examples that demonstrate your expertise!
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team!
How to prepare for a job interview at ProPharma
✨Know Your Quality Standards
Familiarise yourself with Good Pharmacovigilance Practices (GVP), Good Clinical Practices (GCP), and Good Documentation Practices (GDP). Being able to discuss these standards confidently will show that you understand the regulatory landscape and can ensure compliance in your role.
✨Showcase Your Analytical Skills
Prepare examples of how you've gathered and interpreted data in previous roles. Highlight any experience you have with CAPAs, Deviations, and quality KPIs. This will demonstrate your ability to identify trends and outliers, which is crucial for a Clinical Quality Specialist.
✨Communicate Effectively
Practice articulating your thoughts clearly and concisely. Since excellent written and verbal communication skills are essential, consider preparing a few key points about your past experiences that showcase your ability to provide feedback and identify improvements.
✨Be Proactive and Organised
Think of instances where you took initiative or improved processes in your previous roles. Discuss how you prioritise tasks and maintain documentation. This will illustrate your proactive nature and attention to detail, both of which are vital for success in this position.
