EU Qualified Person – Biosimilars Quality Lead (Dublin, Onsite)

Biocon Biologics; Dublin; On-site; EUR 90,000 - 120,000; Full time

Job summary

Biocon Biologics in Ireland is seeking an experienced Qualified Person to support EU GMP release and QP certification for biosimilar products and insulins released to the EU/EEA and other markets. You will ensure batches are certified only when the QP is satisfied with manufacture, testing, and release documentation in compliance with EU GMP and Marketing Authorisations.

Collaborating with QA, Regulatory Affairs, Supply Chain, QC, and external partners, you will oversee the Pharmaceutical

Qualifications

• 5+ years’ experience as a Qualified Person with GMP and pharmaceutical release.
• Eligible to act as QP under EU and national requirements.
• Experience with biological products, insulins, sterile products, and batch certification.

Responsibilities

• Perform QP certification of medicinal product batches in accordance with Directive 2001/83/EC, EU GMP Annex 16 and associated Authorisations.
• Review batch release documentation including manufacturing, packaging, analytical, importation, transport, deviation, OOS/OOT, change control and complaints.
• Ensure each batch for certification is complete, traceable and compliant with requirements and release criteria.
• Assess impact of quality events, investigations, supplier issues, temperature excursions on batch certification.
• Provide QP oversight of the Pharmaceutical Quality System and outsourced GMP/GDP partners.
• Support inspection readiness, regulatory inspections, partner audits, CAPA plans and quality governance.

Skills

Independent judgement

Attention to detail

Regulatory compliance

Communication skills

Risk-based decision making

Education

Pharmacy/chemistry/biology degree

Job description

Biocon Biologics in Ireland is seeking an experienced Qualified Person to support EU GMP release and QP certification for biosimilar products and insulins released to the EU/EEA and other markets. You will ensure batches are certified only when the QP is satisfied with manufacture, testing, and release documentation in compliance with EU GMP and Marketing Authorisations.

Collaborating with QA, Regulatory Affairs, Supply Chain, QC, and external partners, you will oversee the Pharmaceutical