QA Specialist: Drug Product Quality & Compliance

Alexion; Athlone; On-site; EUR 60,000 - 80,000; Full time

Job summary

Alexion Athlone is seeking a QA Specialist for the Drug Product facility to ensure cGMP compliance across manufacturing, testing, labeling and storage. You will oversee the QA activities, coordinate with Operations, QC, Technical Services and Engineering, and support inspection readiness and CAPA management.

The role emphasizes strong documentation control, risk assessments, and deviation/Change Control oversight to safeguard product safety, quality and supply continuity for patients and markets.

Qualifications

• B.Sc. in Science/Engineering with a minimum of 3 years’ experience in cGMP Quality environment; or equivalent combination of education and experience.
• Minimum 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 within a pharma/biopharma company is essential, and will include exposure to FDA, HPRA or other authorities of similar standing.
• Excellent accuracy and attention to detail.
• Good knowledge of relevant computer packages e.g. Trackwise or similar.
• Planning and organizing skills are required to plan, execute and track commitments of Quality Assurance and to adjust to changing priorities.
• Excellent interpersonal skills are required, as is the ability to communicate well, both verbally and written.
• Excellent time management organizational skills along with a proven ability to multi-task.

Responsibilities

• Provide quality and cGMP input and oversight for all manufacturing activities for the Drug Product facility.
• Review and approval of technical support documentation. (Examples include cleaning, process, method validation).
• Review and approval of functional area documentation (e.g. SOPs, Work Instructions, technical reports and protocols)
• Participate in quality risk assessments and provide quality oversight to ensure quality risk assessments are effectively maintained/ controlled.
• Review and approve Validation protocols as required.
• Provide support and expertise for inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, to monitor progress of follow up actions.
• Responsible for review and approval of Master Batch Records in accordance with Alexion's internal procedures and GMP principles.
• Provide oversight of quality management system activities including Preventive Maintenance, Deviation and CAPA Management and Change Control Programs.
• Provide quality oversight of calibration and preventative maintenance criticality assessments as required.
• Author, review and approve Quality Related Procedures as required.
• Support the Vendor/Supplier Management Program.
• Support the Raw Material Qualification Program.
• Develop and report quality metrics
• Oversee the effective documentation and tracking of quality management system activities including deviations, change control and CAPAs.
• Perform day-to-day tasks, as well as assist with projects that support company objectives and continuous improvement initiatives.

Skills

cGMP knowledge

Planning & organizing

Interpersonal skills

Time management

Attention to detail

Multi-tasking

Communication (verbal & written)

Education

B.Sc. in Science/Engineering

Tools

TrackWise

Job description

Alexion Athlone is seeking a QA Specialist for the Drug Product facility to ensure cGMP compliance across manufacturing, testing, labeling and storage. You will oversee the QA activities, coordinate with Operations, QC, Technical Services and Engineering, and support inspection readiness and CAPA management.

The role emphasizes strong documentation control, risk assessments, and deviation/Change Control oversight to safeguard product safety, quality and supply continuity for patients and markets.