Overview
Quality Assurance Specialist (Deviations) Jobs in Dublin, County Dublin, Ireland at Ascend Project Management
Title: Quality Assurance Specialist (Deviations)
Company: Ascend Project Management
Location: Dublin, County Dublin, Ireland
Job Description: QA Specialist (Deviations)
Our client, a global biotechnology company based in South Dublin, is seeking a highly motivated QA Specialist (Deviations) to join their growing team. This is an excellent opportunity to become part of a world-class manufacturing site that plays a key role in the production of life-changing medicines for patients around the globe.
Working within a collaborative and fast-paced environment, you will partner with cross-functional teams to drive operational excellence, maintain the highest standards of quality and compliance, and contribute to the continued success of the site. This position offers the opportunity to work with cutting-edge technologies in a highly regulated biopharmaceutical manufacturing environment while developing your technical expertise and advancing your career within a global organisation committed to innovation and patient care.
Key Responsibilities:
- Provide Quality Assurance oversight for deviations, investigations, CAPAs, and change controls, ensuring activities are completed in a timely, compliant, and effective manner.
- Review and approve quality documentation, ensuring appropriate scope, root cause analysis, risk assessments, and corrective actions are implemented.
- Participate in cross-functional quality review meetings, providing QA guidance and ensuring alignment with quality and regulatory requirements.
- Support complex investigations and offer quality expertise to resolve compliance and operational issues.
- Monitor quality system trends, identify opportunities for improvement, and contribute to continuous improvement initiatives.
- Assist with quality metrics reporting, Annual Product Reviews, and other quality management activities as required.
- Support internal audits, external inspections, and ongoing inspection readiness programmes.
- Ensure all activities are performed in accordance with GMP regulations, company procedures, and applicable quality standards.
- Undertake additional quality-related responsibilities in line with business and operational requirements.
Skills & Experience:
- Bachelor’s degree in Science, Engineering, Pharmacy, Biotechnology, or a related discipline.
- Minimum of 5 years’ experience within the pharmaceutical or biotechnology industry.
- Proven experience providing QA oversight of deviations, investigations, CAPAs, and change controls within a GMP-regulated environment.
- Strong knowledge of GMP regulations, quality management systems, risk assessment, and compliance principles.
- Experience conducting and reviewing root cause investigations and implementing effective corrective and preventive actions.
- Excellent analytical and problem-solving abilities with strong attention to detail.
- Strong communication, stakeholder management, and interpersonal skills, with the ability to collaborate across multiple functions.
- Highly organised with the ability to manage multiple priorities and meet deadlines in a fast-paced environment.
- Experience supporting audits, regulatory inspections, and continuous improvement initiatives within a regulated manufacturing environment.
Contract Information:
- Rate: TBC dependent on level of skills and expertise.
- Start Date: ASAP.
- Schedule: Full time.
- Length of Contract: 12 months with possibility of renewal.
- On-site Schedule: 3 days per week on site.
