Ready to lead projects that bring life-changing treatments to the world? Join our client at the forefront of pharmaceutical innovation and make a difference!
Proclinical is seeking a QA Specialist to support Product Development Quality (PDQ) operations. In this role, you will oversee the manufacture, testing, and distribution of investigational medicinal products (IMPs), ensuring compliance with Good Manufacturing Practices (GMP) and regulatory standards. This position requires a detail-oriented professional with strong organizational skills and the ability to manage multiple projects in a fast-paced environment.
Responsibilities:
- Review batch and test documentation for investigational medicinal products and packaging components.
- Investigate non-conformances and quality incidents, documenting resolutions and deviations.
- Conduct GMP training and provide on-the-job training for new Quality Operations employees.
- Participate in regulatory inspections and internal compliance monitoring programs.
- Review and approve vendor specifications, label proofs, and related documents.
- Utilize electronic verification software for label checks and route final labels for approval.
- Support internal and external audits as required.
- Ensure regulatory GMP/GDP compliance in assigned areas and report deviations to management.
- Collaborate with Trial Supplies Managers on clinical supplies packaging, labeling design, and study requirements.
Key Skills and Requirements:
- Strong attention to detail and ability to concentrate on complex tasks.
- Exceptional project management and organizational skills.
- Solid oral and written communication abilities.
- Proficiency in Microsoft Office Suite (Outlook, PowerPoint, Excel) and willingness to learn additional applications.
- Understanding of regulatory and GMP principles, pharmaceutical terminology, and scientific documentation practices.
- Ability to work effectively in multi-disciplinary teams and deliver results under tight deadlines.
- Educated to degree level in a science-based subject.
- Experience in the pharmaceutical industry or healthcare environment; labeling experience is highly desired.
If you are having difficulty in applying or if you have any questions, please contact Joshua Bye at j.bye@proclinical.com.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
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