Your new company

Your new role

• Being responsible for disposition of medicinal products
• Manage communications with and represent the company during HPRA Inspection.
• Support HPRA inspections and prepare written responses to inspections.
• Prepare and approve HPRA variations.
• Support internal compliance audits of operations.
• Oversee the team in the review and approval of Non-Conformances (NC), CAPA, change controls and complaints.
• Ensure Batch record review to verify compliance with GMP and Market Authorization prior to batch release.
• Assist in the preparation , review and regular update of technical agreements with licensees and 3rd party contractors.
• Organise and schedule periodic review of QMS and operational procedures for regulatory compliance through internal audit system.
• Escalation of issues as appropriate.
• Participating in cross-functional teams as Quality/Qualified Person representative
• Providing advice and direction to other company departments on quality and regulatory issues

What you'll need to succeed

• Previous experience working on licence and eligible to act as a European Qualified Person (QP), certifying products in compliance with 91/412/EEC , EU2019/6 & Annex 16
• A minimum 3 years experience in the necessary testing and checking to ensure the quality of medicinal products.
• The ideal candidate for this role will have a strong background in pharmaceutical manufacturing, quality assurance, and regulatory compliance,
• Excellent attention to detail and problem-solving skills.
• Hold a third level qualification in a scientific discipline – pharmacy, medicine, chemistry, pharmaceutical chemistry and biology.

What you'll get in return

• Increased flexibility around how you want to work.
• Opportunity to work to gain additional and valuable experience working as a contract QP which will stand to you in future career prospects long-term.
• The chance to support a growing company in a role of high responsibility with a broad scope of work.
• Work in a beautiful scenic tourist hotspot while being part of dependable and stable industry.

What you need to do now

If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.

If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.