QP
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
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