Qualified Medicinal Product Specialist
2 weeks ago
We are seeking a highly skilled and experienced Qualified Person to join our team. As a key member of our operations, you will play a critical role in ensuring the quality and compliance of our medicinal products.
Key Responsibilities:- Certify medicinal products in accordance with product marketing authorisation requirements, EU Directives, and relevant Annexes.
- Provide quality and compliance guidance on critical and major quality matters.
- Ensure all necessary manufacturing, packaging, and documentation have been completed and endorsed by authorized staff.
- Maintain independence in decisions on quality-related matters.
You will work closely with cross-functional teams to provide consultative support on quality-related issues and participate in continuous improvement initiatives for GMP compliance.
Requirements:- Third-level qualification in a science-related discipline.
- Eligibility to act as a Qualified Person within the EC/EEA.
- Minimum 3-5 years of QP experience.
- Excellent communication and collaboration skills.
- Extensive pharmaceutical quality experience.
- Thorough knowledge of biopharmaceutical and/or pharmaceutical manufacturing processes and global regulatory GMP/GDP requirements.
As a Qualified Person at our organization, you will have the opportunity to work with recognized subject matter experts, allowing you to be a key player in bringing lifesaving therapies to market. We invest in your future, providing hands-on certifications and professional training.
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