Sterile Drug QA Lead - Start-Up & Compliance

Fastnet; Cork; On-site; EUR 60,000 - 90,000; Full time

Job summary

Fastnet in Ireland is seeking a Quality Assurance professional to support the establishment and start-up of sterile drug product filling operations, transitioning to routine QA support.

Reporting to QA Operations Manager, you will work with cross-functional teams across Quality, Operations, Technical and Project functions, bringing strong GMP knowledge and hands-on experience with sterile manufacturing.

Qualifications

• Minimum 5+ years in a quality role within pharma/biotech.
• Experience with sterile drug product filling is required.
• Strong knowledge of cGMP, FDA and EMA guidelines.

Responsibilities

• Provide QA oversight for start-up and transfer of sterile filling operations.
• Review and approve GMP documentation, including SOPs and batch records.
• Lead deviations, CAPAs and investigations with root cause analysis.
• Support regulatory inspection readiness and product introductions.
• Collaborate with Quality, Operations, Technical and Project teams.
• Support lot release activities and maintenance of quality systems.

Skills

Sterile filling

cGMP compliance

Root cause analysis

Cross-functional teamwork

Education

Science degree or related discipline

Job description

Fastnet in Ireland is seeking a Quality Assurance professional to support the establishment and start-up of sterile drug product filling operations, transitioning to routine QA support.

Reporting to QA Operations Manager, you will work with cross-functional teams across Quality, Operations, Technical and Project functions, bringing strong GMP knowledge and hands-on experience with sterile manufacturing.