Qualified Person

2021-11-11 11:48:162049-03-27Team Horizon
Job TypeContractor
Start Date
AdvertiserAshling Guthrie
Job Ref#2255
Job Views66
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.
Apply Later
Sign in
Ashling Guthrie
Browse Ashling's jobs
Get in touch with Ashling
Similar Jobs
  • QA Compliance Manager
    Ireland, Cork

    If you are passionate about Quality and are an experienced Leader, we have the perfect role for you! We are recruiting for a QA Compliance Manager to join our clients high performing Quality team in Cork. In this management role, you will be responsible for the quality assurance compliance activitie...
  • Quality Systems Manager
    Ireland, Sligo

    Experienced in Quality Systems? Looking to take the next step up in your career? Look no further! Team Horizon have an opportunity for a Quality Systems Manager to join an advanced Biologics Manufacturing site with an exciting future ahead. If you are ambitious and driven to make a real impact on a ...
  • QP
    Ireland, Dublin

    We have an exciting opening for a Qualified Person at our client’s state of the art aseptic manufacturing facility in Dublin. In this role you will be responsible for ensuring each batch of medicinal products has been manufactured and checked in compliance with the requirements of Commission D...
Email Me Jobs Like This
Subscribed to similar jobs notifications
We use cookies to provide you with the best possible browsing experience on our website. You can find out more below.
Cookies are small text files that can be used by websites to make a user's experience more efficient. The law states that we can store cookies on your device if they are strictly necessary for the operation of this site. For all other types of cookies we need your permission. This site uses different types of cookies. Some cookies are placed by third party services that appear on our pages.
Necessary cookies help make a website usable by enabling basic functions like page navigation and access to secure areas of the website. The website cannot function properly without these cookies.
ResolutionUsed to ensure the correct version of the site is displayed to your device.
SessionUsed to track your user session on our website.
Statistic cookies help website owners to understand how visitors interact with websites by collecting and reporting information anonymously.
Google AnalyticsGoogle Analytics is an analytics tool to measure website, app, digital and offline data to gain user insights.

More Details