QA Specialist - Bulk Drug Substance

About the role

Alexion Athlone is looking for a QA Specialist for its Bulk Drug Substance (BDS) facility. The role delivers quality assurance activities so that commercial and clinical products are manufactured in accordance with cGMP, corporate and regulatory requirements, and oversees quality activities linked to the manufacturing and disposition of bulk drug substances. It also ensures effective interaction with other departments and sites on GMP document review and approval.

Key responsibilities

• Provide quality and cGMP input and oversight for all manufacturing activities of the Bulk Drug Substance facility
• Review and approve technical support documentation (cleaning, process, method validation) and functional area documentation (SOPs, work instructions, technical reports and protocols)
• Participate in quality risk assessments and oversee them
• Review and approve validation protocols and master batch records
• Support inspection readiness, including interaction with inspectors, responses to observations and follow-up actions
• Oversee quality management system activities such as preventive maintenance, deviations, CAPA management and change control, and calibration and preventive maintenance criticality assessments
• Author, review and approve quality-related procedures, support vendor/supplier and raw material qualification programs, develop and report quality metrics, and track quality activities
• Perform day-to-day tasks and assist with projects supporting company objectives and continuous improvement

Required profile

• B.Sc. in Science or Engineering with at least 3 years' experience in a cGMP quality environment, or equivalent education and experience
• At least 3 years' experience in a QA environment within the pharma industry or a related field
• Strong knowledge of cGMP requirements for pharmaceutical manufacturing
• Direct experience of GMP management in a pharma/biopharma company, including exposure to FDA, HPRA or similar authorities
• Excellent accuracy, attention to detail, planning and organisational skills, and strong verbal and written communication
• Proven ability to multi-task and manage time

Required skills

• Good knowledge of computer packages such as Trackwise or similar
• Preferred: sterility assurance experience, auditing, pharmaceutical manufacturing and regulatory inspection management