Qualified Person (QP)

Our client is on the search for a Qualified Person and play a key role in maintaining top-tier quality standards! If you have a keen eye for detail and a passion for compliance, this could be your perfect opportunity.

Proclinical is seeking a Qualified Person to support the importation and batch certification of medicinal products into the European Union. This role also involves maintaining and implementing a Quality Management System to ensure compliance with GMP standards and regulatory requirements. You will play a key part in enhancing quality policies, systems, and procedures while ensuring operations align with industry standards.

Responsibilities:

• Review and disposition batches for imported commercial products into the EU.
• Conduct Confirmation QP activities in compliance with EU GMP requirements.
• Implement and maintain compliance with GMP and GDP standards, including training and mentoring staff.
• Write, review, and approve procedural documents.
• Execute internal and external audits as per schedules.
• Manage and host competent authority inspections.
• Review and approve Quality Agreements, Product Quality Review reports, deviations, and customer complaints.
• Support investigations and corrective actions related to complaints and deviations.
• Act as a Quality Subject Matter Expert for projects as required.
• Perform additional duties as requested by senior leadership.

Key Skills and Requirements:

• Registration as a Qualified Person under relevant EU regulations.
• Strong knowledge of Quality Assurance, Quality Systems, and GMDP across various dosage forms.
• Familiarity with European regulations on manufacturing, importation, distribution, and trade.
• Technical and scientific judgment with the ability to translate GMP guidelines into effective processes.
• Fluency in English and proficiency in French or Dutch.
• Proactive and diplomatic with advanced problem-solving and decision-making skills.
• Strong project management, communication, and negotiation abilities.
• Competent in using tools like Word, Excel, and PowerPoint.

If you are having difficulty in applying or if you have any questions, please contact Josh Godden at j.godden@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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