Senior Qualified Person — Batch Approval & Quality Leadership

Claran Consultants Ltd

Limerick

On-site

EUR 120,000 - 180,000

Full time

3 days ago

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Job summary

Claran Consultants Ltd. in Ireland seeks a Qualified Person to collaborate across departments, mentor QA teams, and lead technical quality initiatives. You will approve batches, supervise regulatory submissions, and ensure adherence to cGMP and data integrity standards.

The role requires a Level 7+ science/engineering degree, licensed QP status, and at least six years of relevant experience. You will operate within a biotech manufacturing setting, with focus on Annex 16 compliance and strong

Qualifications

Must be approved by member state as a licensed QP to be named on the company license.
Level 7 qualification or higher in Science, Engineering or related discipline.
Minimum 6 years relevant experience.

Responsibilities

Batch approval: ensure biotech drug substance batches are certified and compliant with regulations.
Ensure biotech drug product batches are tested per MAAs/CTDs.
Final decision authority on batch certification.
Provide quality leadership, direction and governance for the area.
Carry out day-to-day activities in line with site safety policies.
Promote safe practices and promptly report safety concerns.
Maintain knowledge aligned with Annex 16 and scientific progress.
Review and approve quality-related documents.
Approve GMP documents including change controls, IQ/OQ/PQ, validation documents.
Monitor GMP compliance and perform site self-inspections.
Support regulatory submissions and issue QP declarations.