Qualified Person

We are seeking applications for an experienced contract QP for our client, who are a leading biopharmaceutical company. This role is based in Dublin, but can be a mix of remote and onsite work. In this role you will be responsible for ensuring that licensed Finished Product is certified and released to market in accordance with EU directive 2001/83/EC, 2004/94/EC and in accordance with the requirements of Annex 16.
 
 
Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.


• Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.

What you will be doing:

• QP release of products across the 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 diseases


• QP Partner with Finished Product Operations team for on time release


• Ensure independence of the QP on decisions on quality related matters.


• 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 matters


• Perform QP quality review and approval for Annual Product Quality Review


• Provide Quality oversight, input into quality documents e.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 perspective


• Support Regulatory Inspections and be a representative in front of Health Authorities and Regulatory Bodies


• Provide audit support as required for internal auditing program and supplier audits.


• 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 practice

What you need to apply:

• 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 preferable


• 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.