Qualified Person

Summary:

Our client has an exciting opportunity for a Qualified Person to join the team in a large biopharmaceutical company. If you are someone who wants to be part of an organisation that brings life-changing medicines to those who need them, this could be the career step for you!

Responsibilities:

• The Qualified Person (QP) is responsible for fulfilling QP responsibilities in relation to batch release of commercial and clinical product, in accordance with the requirements of 2001/83/EC, 2001/20/EC, Annex 16 and Annex 13 requirements as applicable.
• The QP ensures all products certified have been manufactured in accordance with the requirements of its marketing authorisation/ CTA and are in compliance with cGMP requirements.
• Provide technical expertise for all QA and compliance topics /issues relating to manufacturing and product supply of drug products and finished goods.
• Routinely monitoring the company's operations to ensure compliance with site licenses and Good Manufacturing Practices bringing any critical and major deficiencies to the attention of the Head of Quality Assurance.
• Participate in management reviews of process performance, product quality and of the quality management system in order to identify and action opportunities for continual improvement.
• Participates in cross-functional teams as the Quality/Qualified Person representative.
• Reviews and approves Product Quality Reviews.

Requirements:

• QP Qualification with at least 8 years of Quality experience in an EU-licensed facility in a relevant functional area.
• Qualified Person status achieved with min 3-5 years of relevant work experience acting as Qualified Person named on a Manufacturing and Importation Authorisation (MIA/ IMP MIA).
• Aseptic / Sterile Drug Product manufacturing experience desirable.
• Experience with IMP's (Investigational Medicinal Products) desirable.
• Experience with participation in regulatory inspections, presenting or defending departmental functions in audits or regulatory inspections.
• Understanding and familiarity with European/ FDA regulatory requirements, guidelines, and expectations.
• Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
• Maintain knowledge up to date with respect to the current Good Manufacturing Practices (cGMP), technologies and quality systems for the products they certify.

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