Qualified Person

Claran Consultants Ltd; Limerick; On-site; EUR 120,000 - 180,000; Full time

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.

Skills

Licenced Batch Approval

Quality Documents

Regulatory Submission

cGMP

Data Integrity

Quality Leadership

Education

Science/Engineering degree (Level 7+)

Licensed QP status (approved by member state)

Job description

Job Description

The Qualified Person will collaborate with various departments to support the technical agenda and serve as a technical mentor for the site quality assurance teams.

Educational / Qualifications:

Required 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

Preferences:

Strong understanding and working knowledge of cGMP, FDA, Data Integrity, Quality Risk Management and other biopharmaceutical regulatory requirements. Demonstrated proficiency in planning and the ability to carry out tasks with a high degree of independence as well as being able to work in a team environment. Demonstrated success in influencing without authority. Demonstrated ability to write technical documents, develop business presentations and effectively communicate concepts to a wide range of personnel including senior leadership.

Key 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.
• Technical Leadership Provide Quality leadership, direction and governance for the specific area of responsibility.
• Carry out day to day activities in compliance with site safety policy and procedure.
• Promote and encourage safe practices and promptly report any safety concerns.
• Continue to maintain knowledge and experience in line with technical and scientific progress for product(s) of responsibility in alignment with Annex 16.
• 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.

Skills:

Licenced Batch Approval Quality Documents Regulatory Submission cGMP TPBN1_IJ