Global Quality Ops Specialist – Europe

RXinsider LTD.; Dublin; Hybrid; EUR 90,000 - 120,000; Full time

Job summary

Azurity Pharmaceuticals is seeking a Senior Specialist, Quality Operations Europe & International Quality Operations, to support the Director in maintaining GMP and GDP compliance across Europe and international markets.

The role provides oversight of quality systems, commercial product quality activities, external vendors, and licensed activities associated with the site Manufacturing & Importation Authorisation (MIA) and Wholesale Distribution Authorisation (WDA).

Qualifications

• 5+ years of pharmaceutical quality experience in GMP and GDP environments.
• Experience managing quality systems (deviations, CAPAs, change controls, complaints).
• Knowledge of EU GMP and GDP regulatory requirements.
• Experience supporting contract manufacturers, testing laboratories, transporters and distributors.
• Strong organizational and communication skills.

Responsibilities

• Support quality oversight of MIA and WDA licensed activities in Ireland.
• Coordinate qualification, approval, and ongoing monitoring of contract manufacturers, testing laboratories, warehouses, transporters and distribution partners.
• Manage quality events including deviations, OOS investigations, CAPAs, change controls, complaints
• Manage Product Quality Reviews (PQR) and quality risk assessments.
• Ensure timely investigation, documentation, and closure of quality records in accordance with company procedures.
• Support batch release, distribution, and market supply activities by ensuring required quality documentation is reviewed and maintained.
• Verify compliance of manufactured products with approved Marketing Authorizations, GMP, GDP, and company quality standards.
• Verify compliance of suppliers and customers (bona fide checks) for the authorized activities.
• Support management of product returns, quality defect notifications, product recalls, and Health Authority reporting requirements.
• Participate in vendor audits, self-inspections, and compliance assessments and track completion of resulting CAPAs.
• Monitor quality metrics and identify compliance risks, trends, and opportunities for continuous improvement.
• Escalate quality and compliance issues through established governance processes.

Skills

Quality systems management

GxP compliance

Regulatory knowledge EU GMP/GDP

Vendor audits

Documentation/CAPA handling

Analytical/problem-solving

Communication skills

Education

Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or related field

Tools

Veeva Quality Vault

Job description

Azurity Pharmaceuticals is seeking a Senior Specialist, Quality Operations Europe & International Quality Operations, to support the Director in maintaining GMP and GDP compliance across Europe and international markets.

The role provides oversight of quality systems, commercial product quality activities, external vendors, and licensed activities associated with the site Manufacturing & Importation Authorisation (MIA) and Wholesale Distribution Authorisation (WDA).