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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