Qualified Person / QP, On Licence (12M, Limerick)

QUALIFIED PERSON/ QP with at least 2+ years experience as a QP on a license required by CareerWise Recruitment for our multinational Biologics client in Limerick. Initial 12 month contract on offer. On-site presence required in Limerick at least 3 days a week. At least 2+ years working as a QP on a licence. At least 6+ years overall working in QA / Quality.

RESPONSIBILITIES

Batch Approval Ensures manufactured biotech drug substance (DS) batches are certified in accordance with all required regulations and in compliance with IND/CTAs/manufacturing authorization/ marketing authorization. Ensure that biotech drug product batches are tested in compliance with manufacturing & marketing authorizations (BLA/MAAs/ROW CTDs). Is responsible for the final decision associated with batch certification.

Document Review/Approval

Responsible for approving appropriate quality-related documents. An approval signature confirms that GMP and relevant regulatory requirements have been met. As per the requirements of local procedures, review and approval of change controls, deviations, failure investigations, suspect analytical results, product quality complaints, stability studies and reports associated with the manufactured batches. As per the requirements of local procedures, review and approval of GMP documents associated with qualification and validation including but not limited to change controls, IQ/OQ/PQ & validation documents for facility, equipment, computer systems, GMP utilities, analytical methods, and processes, stability data and periodic review reports (PRR) and annual product reviews (APR) product quality evaluations.

Quality Monitoring Programs

Monitoring of GMP compliance and verification of the effective implementation of key GMP programs and systems by ensuring a regular presence in the area of responsibility. Monitoring of the Site Self-Inspection program and audit of production, systems and service areas for compliance with Product Quality Systems, policies, guidelines and procedures.

Regulatory Submission & RTQ Support

Responsible for issuance of QP declarations where required. Understand the conditions and requirements when a renewed authorization is necessary and ensure they are complied with.

EDUCATIONAL REQUIREMENTS / QUALIFICATIONS

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