Qualified Person

Job title:

Qualified Person

Company

Morgan McKinley

Job description

Our client is looking for a Qualified Person to join their team. In this role, you will provide quality assurance oversight across all activities within the business unit, ensuring adherence to essential GMP standards.As the QP, you will be responsible for certifying the manufacturing of all batches in alignment with marketing authorization requirements and GMP guidelines.This role comes with the legal responsibility for batch disposition, and you must be listed on the manufacturing authorizations. You will collaborate closely with the Director of QA to meet key goals and objectives, ensuring compliance with regulatory standards set by the FDA, EU, and relevant Ministries of Health.Key Responsibilities

• Ensure that all batches produced within the business unit are in full compliance with marketing authorization and GMP standards.
• Oversee and validate all documentation generated by the business unit, such as batch records, exception reports, validation documents, and product quality review reports.
• Resolve any issues related to non-conformances and outstanding actions within the business unit.
• Lead investigations into non-conforming materials or products and make decisions on their release or disposition.
• Supervise the QA and Product Release teams within the business unit, ensuring that all product releases and associated activities are fully compliant.
• Inspire and guide employees to adhere to GMP standards by fostering clear and effective communication.
• Provide leadership and direction to all quality-related teams, including QC, Product Release, Compliance, and Bioassay, ensuring proper execution of quality practices.
• Offer quality insights and recommendations on proposed changes to processes within the business unit.
• Oversee the quality assurance aspects of new product introductions, ensuring compliance with all relevant requirements.

Qualifications

• Degree in Pharmaceutical Science or a relevant scientific discipline.
• Recognized QP qualification.
• Minimum of 5 years’ proven experience in a quality discipline within the Pharma/Medical Device environment.

Expected salary

Location

Ireland

Job date

Wed, 02 Apr 2025 00:32:45 GMT

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