Pharma Quality Leader: GDP & HPRA Compliance

Auxilia Group Recruitment; Leinster; On-site; EUR 70,000 - 100,000; Full time

Job summary

Auxilia Group Recruitment is assisting a client in the pharmaceutical sector in Dublin with an experienced Quality Manager role. You will work within the Quality team, interact with colleagues across functions, and drive GDP and HPRA compliance across all distribution activities.

You will oversee supplier and transport provider approvals, draft procedures, perform Bona Fide checks, manage change control and participate in Quality Reviews and risk management discussions.

Qualifications

• Broad quality function experience in pharmaceutical distribution or life sciences GDP environments.
• Experience with Good Distribution Practice (GDP) and supply chain management.
• Awareness of FMD and sterilization.
• Compliant with GDP and HPRA regulations and company policies.
• Proficiency with quality management systems and MS Office.

Responsibilities

• Work within the existing Quality team and engage with colleagues across all functions, a hands-on role across all levels of the quality function.
• Ensure GDP and HPRA guidelines are adhered to across all GDP activities.
• Assist in approval of outsourced service providers and route qualifications for transport providers.
• Draft new procedures and release to team on approval by the RP.
• Complete Bona Fide checks on suppliers and customers as assigned.
• Facilitate and attend regular management meetings including Quality Reviews and Risk Management Reviews.
• Report all temperature excursions to the RP and COO, including excursions in warehouse and on-route to customers.
• Manage Change Control and document for COO and RP approval.
• Review and update Quality Technical Agreements with suppliers, customers, and outsourced service providers.

Skills

Quality management

GDP / HPRA compliance

MS Office proficiency

Quality systems

Driver's license and car

Education

Degree in science, Quality, Engineering or related field

Tools

Microsoft Office

Quality management software

Job description

Auxilia Group Recruitment is assisting a client in the pharmaceutical sector in Dublin with an experienced Quality Manager role. You will work within the Quality team, interact with colleagues across functions, and drive GDP and HPRA compliance across all distribution activities.

You will oversee supplier and transport provider approvals, draft procedures, perform Bona Fide checks, manage change control and participate in Quality Reviews and risk management discussions.