
Pharmaceutical Quality Expert
1 day ago
We are seeking a seasoned Quality Assurance Specialist to join our team in Ireland. The ideal candidate will possess strong expertise in pharmaceutical quality and compliance.
- Key Responsibilities:
- •Certify medicinal products in accordance with marketing authorization requirements, EU Directives, and Annex 13/16 as applicable for Investigational Medicinal Products.
- •Provide guidance on critical and major quality matters, ensuring adherence to established procedures.
- •Lead quality direction and oversight for projects related to processes, product, and compliance.
- •Ensure the independence of the Qualified Person on decisions regarding quality-related matters.
- •Support investigations and discrepancy resolution, providing expert knowledge in pharmaceutical legislation and industry practices.
- •Collaborate with cross-functional teams to address quality-related issues and drive continuous improvement initiatives.
- •Maintain up-to-date knowledge of pharmaceutical legislation and industry best practices.
Requirements:
- Qualifications:
- •Third-level qualification in a science-related discipline.
- •Demonstrated ability to act as a Qualified Person within EC/EEA.
- •Minimum 3-5 years of experience as a QP.
- Skills:
- •Excellent communication skills, including written, interpersonal, collaboration, and negotiation skills.
- •Thorough knowledge of biopharmaceutical and/or pharmaceutical manufacturing, packaging, testing, and distribution processes, as well as global regulatory GMP/GDP requirements.
- •Audit experience is beneficial.
- •Strong task management skills, prioritizing, scheduling, and controlling under tight deadlines.
Benefits:
We offer a competitive salary package, excellent career development opportunities, and a collaborative work environment. Our company values diversity and promotes a culture of inclusion and respect.
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