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Principal Specialist Consultant at BioTalent, part of the IN Group | Quality within Pharma, Biopharma and Biotech - DACH - EU
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
Please apply or email your resume with your availability to have a confidential discussion about this opportunity.
BioTalent Ltd is acting as an employment agency in relation to this opportunity.
Additional Information:
* Seniority level: Mid-Senior level
* Employment type: Full-time
* Job function: Quality Assurance, Research, and Manufacturing
* Industries: Pharmaceutical Manufacturing, Biotechnology Research, and Manufacturing
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