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- Tasks: Ensure investigational products meet quality and safety standards for clinical trials.
- Company: Join a leading organization in the pharmaceutical industry making a real impact.
- Benefits: Be part of a dynamic team with opportunities for mentorship and professional growth.
- Why this job: Make a difference in healthcare while working in a fast-paced, innovative environment.
- Qualifications: Bachelor's or Master's degree in relevant fields and QP certification required.
- Other info: Ideal for detail-oriented professionals passionate about quality assurance and regulatory compliance.
The predicted salary is between 48000 - 72000 £ per year.
Qualified Person – IMP (Investigational Medicinal Products) Are you a driven and detail-oriented professional looking to make a significant impact in the pharmaceutical industry? Our client, a leading organisation in the field, is seeking a Qualified Person (QP) for Investigational Medicinal Products (IMPs) to join their dynamic team in the Netherlands. If you have a passion for quality assurance and regulatory compliance, this is the perfect opportunity for you! Key Responsibilities: As the QP for IMPs, you will play a crucial role in ensuring that investigational products meet the highest quality and safety standards. Your key responsibilities will include: IMPs Release and Certification: Certify the release of IMPs for clinical trials, ensuring adherence to EU GMP Annexe 13 requirements and product specifications. Quality Oversight: Provide quality oversight for manufacturing, testing, and distribution activities, ensuring compliance with GMP and Good Clinical Practise (GCP). Documentation Review: Review and approve batch manufacturing records, validation protocols, and analytical data to verify compliance with GMP requirements. Regulatory Compliance: Stay updated on evolving EU and international GMP regulations, providing guidance and support to project teams. Training and Development: Mentor Quality Assurance staff and cross-functional team members on GMP requirements for IMPs. Qualifications: We're looking for candidates who possess the following qualifications and experience: Education: Bachelor's or Master's degree in Pharmacy, Biotechnology, Chemistry, or a related field. QP Certification: Must be a certified Qualified Person (QP) recognised under EU Directive 2001/20/EC with experience in IMP certification. Experience: A minimum of 5 years in Quality Assurance or a similar role within the pharmaceutical industry, with a focus on IMPs. Technical Skills: Strong problem-solving and analytical skills, excellent written and verbal communication in English, and the ability to manage multiple priorities in a fast-paced environment.Preferred Skills: Experience with regulatory inspections (e.g., EMA, MHRA). Familiarity with quality management systems (QMS) and electronic documentation systems
QP - IMP (Investigational Medicinal Products) employer: Adecco
Contact Detail:
Adecco Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land QP - IMP (Investigational Medicinal Products)
✨Tip Number 1
Make sure to highlight your QP certification and relevant experience in your conversations. This role requires a strong understanding of EU GMP Annexe 13, so be prepared to discuss how you've applied these regulations in your previous positions.
✨Tip Number 2
Network with professionals in the pharmaceutical industry, especially those who have experience with IMPs. Attend industry conferences or webinars where you can meet potential colleagues and learn more about the latest trends and challenges in quality assurance.
✨Tip Number 3
Stay updated on the latest EU and international GMP regulations. Being knowledgeable about recent changes can set you apart during discussions and demonstrate your commitment to regulatory compliance.
✨Tip Number 4
Prepare to showcase your mentoring skills. As a QP, you'll be expected to guide others on GMP requirements, so think of examples where you've successfully trained or supported team members in the past.
We think you need these skills to ace QP - IMP (Investigational Medicinal Products)
Some tips for your application 🫡
Highlight Relevant Experience: Make sure to emphasize your experience in Quality Assurance, particularly in the context of Investigational Medicinal Products (IMPs). Detail your previous roles and responsibilities that align with the key responsibilities listed in the job description.
Showcase Your QP Certification: Clearly state your Qualified Person (QP) certification and ensure it is prominently featured in your CV. Mention any relevant training or courses that support your qualifications for this role.
Demonstrate Knowledge of Regulations: Discuss your familiarity with EU GMP regulations and any experience you have with regulatory inspections. This will show that you are well-versed in the compliance aspects crucial for the position.
Tailor Your Cover Letter: Craft a personalized cover letter that reflects your passion for quality assurance and regulatory compliance. Use specific examples from your career to illustrate how you can contribute to the organization’s goals.
How to prepare for a job interview at Adecco
✨Showcase Your QP Certification
Make sure to highlight your QP certification during the interview. Discuss how your certification aligns with the EU Directive 2001/20/EC and share specific examples of how you've applied this knowledge in your previous roles.
✨Demonstrate Your Quality Oversight Experience
Prepare to discuss your experience in providing quality oversight for manufacturing, testing, and distribution activities. Be ready to give concrete examples of how you ensured compliance with GMP and GCP standards in past projects.
✨Stay Updated on Regulatory Changes
Show your commitment to staying informed about evolving EU and international GMP regulations. You can mention any recent changes you've followed and how they might impact the role of a QP for IMPs.
✨Emphasize Your Mentoring Skills
Since mentoring is part of the role, be prepared to discuss your experience in training and developing Quality Assurance staff. Share specific instances where you successfully guided team members on GMP requirements.
