Senior Quality Manager

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 are currently recruiting for an experienced Quality Manager on behalf of our client operating in the pharmaceutical industry. This is a permanent opportunity based in Co. Dublin.

Job Role:

• Working within the existing Quality team and engaging with colleagues across all functions of the business, this is a broad and hands on role, and the successful candidate will need to be comfortable working across all levels of the qualify function.
• Ensure Good Distribution Practice and current Health Products Regulatory Authority (HPRA) guidelines are adhered to covering all GDP activities performed.
• Assist in the approval of outsourced service providers and assist in route qualifications of transport providers as planned and required.
• Draft new procedures required for the company and release to team on approval by the RP.
• Complete relevant initial and ongoing Bona Fide checks on suppliers and customers as assigned.
• Facilitate and attend regular management meetings which include Quality Reviews and Risk Management Reviews.
• Reporting all temperature excursions as they arise to the RP and COO, to include temperature excursions within the warehouse, upon receipt from suppliers and on-route to customers as applicable.
• Change Control – Identify changes as needed and required and document the change control for approval of the COO and the RP.
• Review and update Quality Technical Agreements as required and ensure Technical Agreements are in place with all suppliers, customers, and outsourced service providers.

Requirements:

• Degree in science, Quality, Engineering or related field
• Strong experience in a broad quality role in a pharmaceutical distribution or other life science GDP environment.
• Experience in Good Distribution Practice and supply chain management is essential.
• FMD and Sterilization awareness.
• Adheres to and follows all procedures policies and guidelines ensuring compliance with GDP and HPRA regulations and company policies, procedures, and guidelines.
• Proficiency in Microsoft Office and quality management systems.
• Full clean drivers' licence and own car required for travel between sites.