At a Glance
- Tasks: Ensure quality compliance and improve clinical services through data analysis and reporting.
- Company: ProPharma, a leader in biotech and pharmaceutical consulting.
- Benefits: Competitive salary, professional development, and a supportive work environment.
- Other info: Opportunity for growth in a dynamic and impactful industry.
- Why this job: Join a team making a real difference in patient health and innovative therapies.
- Qualifications: Degree in relevant field and 2 years in Quality Assurance.
The predicted salary is between 35000 - 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.
Experience RequirementsMinimum 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 employer: ProPharma
ProPharma is an exceptional employer that prioritises the health and wellness of patients while fostering a collaborative and innovative work environment. With a strong commitment to employee growth, ProPharma offers continuous training and development opportunities, ensuring that team members are equipped with the latest industry knowledge and skills. Located in a vibrant area, employees enjoy a supportive culture that values quality and compliance, making it an ideal place for those seeking meaningful and rewarding careers in clinical quality assurance.
StudySmarter Expert Advice🤫
We think this is how you could land Clinical Quality Specialist
✨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 noticed. We’re always looking for passionate individuals who want to make a difference in the healthcare sector.
We think you need these skills to ace Clinical Quality Specialist
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, especially with GxP systems, 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 concise but impactful – we love a good story!
Showcase Your Analytical Skills:Since the role involves analysing data and identifying trends, make sure to include examples of how you've successfully used your analytical skills in past roles. We’re looking for someone who can dig deep and provide insights!
Apply Through Our Website:Don’t forget to apply 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 serious about joining our team!
How to prepare for a job interview at ProPharma
✨Know Your Quality Standards
Make sure you brush up on 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 core of what ProPharma values in a Clinical Quality Specialist.
✨Showcase Your Analytical Skills
Prepare examples from your past experience where you've successfully gathered and interpreted data. Highlight any instances where you identified trends or outliers, as this is crucial for the role. Use specific metrics or outcomes to illustrate your impact.
✨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 previous experiences that demonstrate your ability to provide feedback and identify improvements.
✨Be Proactive and Organised
Think of ways you've demonstrated proactivity in your previous roles. Be ready to discuss how you prioritise tasks and maintain documentation. Showing that you can work with minimal supervision while keeping everything organised will set you apart.
