Senior Quality Auditor
Location: Santry, Dublin (1 day on site a week)
Travel: National and International
Our client is a forward-thinking pharmaceutical company committed to delivering quality medicines that make a meaningful difference in the lives of patients. They are seeking a highly motivated and experienced Senior Quality Auditor to join their team. This role offers the opportunity to contribute to global healthcare while ensuring compliance and quality in supplier management.
What You'll Do:
- Mentor and develop team members to support their professional growth.
- Oversee the lifecycle management of the client's approved vendors and suppliers in line with industry regulations and guidelines.
- Collaborate cross-functionally with departments like Supply Chain, Regulatory, and Quality to ensure alignment of qualification activities with business needs.
- Travel nationally and internationally as part of the role's responsibilities.
- Deputize for the Senior Quality Manager - Supplier Assurance as required.
- Establish and monitor KPIs, providing evaluations and reporting on related metrics.
- Manage a risk-based audit program for vendors and suppliers used in the client's products (excluding Pharmacovigilance suppliers/partners).
- Conduct risk analysis-based outcomes on Quality audits, collaborating with QPs and management on follow-up actions.
- Ensure audits meet current EU GMP, EU GDP, or equivalent standards, as well as relevant marketing authorization (MA) requirements.
- Maintain and track CAPAs (Corrective and Preventive Actions) internally and with external suppliers.
- Keep vendor data valid and up to date in the SAP ERP system.
- Evaluate and interpret global regulations for audit activities.
- Create, revise, and review documentation related to QA audit checklists, questionnaires, and other SOPs/guidance documents as required.
- Support additional activities at the discretion of the Senior Quality Manager - Supplier Assurance.
Requirements:
- A degree in Chemistry, Pharmacy, Microbiology, or a related field
- General Auditing Qualification.
- External Lead Auditing Qualification.
- At least 2 years of experience in a similar role within the pharmaceutical industry.
- Strong organizational skills with the ability to prioritize and work under pressure.
