EU Qualified Person

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

At Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient-centricity, and disruptive thinking. We are a multicultural global company where employees have a purpose and passion to work closely with partners and patients. We have a long-term commitment to bringing high-quality affordable biosimilars to patients all over the globe. We have proven end-to-end expertise from clone development, manufacturing, clinical development, and regulatory approvals to commercialization.

Qualified Person

QP Certification | EU GMP | MIA Oversight | Biological Medicinal Products and Insulins

Location: Dublin, Ireland || Onsite

About the Role

We are seeking an experienced Qualified Person to support the BBIRL Manufacturing and Import Authorisation and provide QP certification and quality oversight for biosimilar and biological medicinal products and insulins released to the EU/EEA and other markets supplied under the BBIRL MIA. This role has direct accountability for ensuring batches are certified only where the QP is satisfied that manufacture, importation, testing, documentation and release are compliant with EU GMP, the Marketing Authorisation, Quality Agreements and internal procedures.

The role works closely with QA, Regulatory Affairs, Supply Chain, QC, Internal Biocon and contract manufacturers, contract laboratories and logistics partners to support compliant batch certification, patient safety, inspection readiness and continuity of supply.

Key Responsibilities

• Perform QP certification of medicinal product batches in accordance with Directive 2001/83/EC, EU GMP Annex 16, the applicable Marketing Authorisation, internal procedures and Quality Agreements.
• Review batch release documentation, including manufacturing, packaging, analytical, importation, transport, deviation, OOS/OOT, change control and complaint information.
• Ensure each batch presented for certification is complete, traceable, scientifically justified and compliant with registered requirements, GMP expectations and product-specific release criteria.
• Assess the impact of quality events, investigations, supplier issues, temperature excursions and regulatory risks on batch certification and product disposition.
• Provide QP oversight of the Pharmaceutical Quality System and outsourced GMP/GDP partners supporting products under the BBIRL MIA.
• Support inspection readiness, regulatory inspections, partner audits, deficiency responses, CAPA plans and quality governance activities where QP input is required.

Qualifications and Experience

• Eligible to act, or already approved to act, as a Qualified Person in accordance with applicable EU and national requirements.
• Degree in pharmacy, chemistry, biology, biotechnology, pharmaceutical sciences, life sciences or related discipline, with appropriate QP educational qualification and practical experience.
• 5+ years’ experience as a Qualified Person, with significant GMP quality experience ideally including biological products, insulins, sterile products, importation, batch certification, outsourced manufacturing or contract laboratory oversight.
• Strong working knowledge of EU GMP, Annex 16, Annex 21, GDP, Marketing Authorisation compliance, Pharmaceutical Quality Systems, quality risk management, data integrity and batch release requirements.
• Experience reviewing batch records, analytical data, deviations, OOS/OOT investigations, CAPAs, change controls, complaints, Quality Agreements and inspection evidence packs.

Skills and Competencies

• Strong independent technical judgement and ability to make defensible QP certification decisions.
• Excellent attention to detail and ability to identify documentation gaps, data integrity concerns, quality risks and regulatory compliance issues.
• Clear understanding of QP personal accountability and legal responsibilities associated with batch certification.
• Strong communication, escalation and influencing skills across internal teams and external partners.
• Pragmatic, risk-based and patient-focused approach to quality decision-making.

Biocon Biologics is an Equal Opportunity, EEO / Aff All qualified applicants will receive consideration for employment without regard to, and no employee shall be discriminated against because of their race, color, religion, age, sex (including pregnancy), national origin, disability, genetic information, status as a protected veteran or any other characteristic protected by applicable federal, state or local law.