13955633 – Qualified Person – Dublin Contractor

Purpose:

The Qualified Person is responsible to ensure that licensed Finished Product to include Drug Substance, Drug Product is certified and released to market by a Qualified Person named on the commercial manufacturing license in accordance with EU directive 2001/83/EC, 2004/94/EC and in accordance with the requirements of Annex 16.

To ensure that investigational medicinal product (IMP) is certified and released to sponsor by a Qualified Person named on the IMP Manufacturing License in accordance with EU directive 2001/20/EC and in accordance with the requirements of Annex 16 and Annex 13.

Responsibilities:

• QP release of company products across the company network and contract manufacturing operations to ensure commercial and clinical drug substance, drug product and finished products are certified in accordance with GMP and MA/IMPD to support patient supply for rare
• QP Partner with Finished Product Operations team for on time
• Ensure independence of the QP on decisions on quality related
• Builds partnerships across the business to create a culture that demonstrates excellence in quality, compliance and continuous improvements.
• Provide quality and compliance guidance on all critical and major quality.
• Perform QP quality review and approval for Annual Product Quality Review.
• Provide Quality oversight, input into quality documents g. QAGs, customer complaints as required.
• Creates an environment for ‘right first time’ in focusing on principles of lean, visual management and building in efficiencies as necessary from a systematic and compliance.
• Support Regulatory Inspections and be a representative for the company in front of Health Authorities and Regulatory Bodies
• Provide audit support as required for internal auditing program and supplier.
• Provide support to Regulatory for Regulatory submissions (IMPD, MAA) / QP declarations and License updates.
• Maintain an up-to -date knowledge of pharmaceutical legislation and industry.

Minimum Qualifications & Requirements:

• Preference given to candidates with advanced degrees; eight or more years of cGMP experience preferred; consideration will be given to other relevant experience and education.
• Minimum 8 – 10 years GMP related experience in biopharmaceutical /pharmaceuticals.
• Eligible and demonstrated ability to act as Qualified Person within EC/EEA.
• Minimum 2 years QP experience.
• Must have excellent communication skills, including excellent written, interpersonal, collaboration, and negotiation skills, with a team-oriented approach.
• Extensive demonstrated pharmaceutical quality experience.
• Must have thorough knowledge of biopharmaceutical manufacturing, packaging, testing, and distribution processes and associated global regulatory GMP/GDP requirements.
• Must have demonstrated understanding of the processes and interactions essential for ensuring and maintaining regulatory compliance.
• Must have strong task management skills with the ability to prioritize, schedule, and control under tight deadlines.