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QP

Remote, USA Full-time Posted 2025-11-03
Qualified Person – Global Pharmaceutical Organisation - EU (Remote) BioTalent is partnered with a leading pharmaceutical organisation to support the hire of a Qualified Person, with expertise across GMP compliance, quality systems, and third-party manufacturing oversight. This role will offer you: • A key position in batch certification and EU product release • Collaboration with global manufacturing partners and suppliers • Involvement in audits, regulatory inspections, and quality improvement initiatives • Ongoing training and development in EU-GMP and GDP standards Key Responsibilities: • Certify medicinal product batches for EU release • Review manufacturing/packaging records and technical agreements • Conduct internal audits and third-party inspections to EU-GMP/GDP standards • Investigate deviations, complaints, and implement CAPAs • Maintain and improve SOPs and internal quality systems • Approve and monitor third-party suppliers and manufacturing partners Key Requirements: • Bachelor's Degree in Pharmacy (QP eligibility required) • 5+ years' experience in a similar QA or QP role • Strong understanding of EU-GMP, GDP, and regulatory compliance • Experience in batch certification and quality audits • Excellent communication and documentation skills • Proficient in standard computer and quality systems Apply Job! Apply to this Job

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