QA Associate - Shift

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

This role will provide Quality Assurance support for the establishment and start-up of sterile drug product filling operations, before transitioning into routine QA support for the facility.

Reporting to the QA Operations Manager, the successful candidate will work closely with cross-functional teams across Quality, Operations, Technical and Project functions. The role requires a proactive Quality professional with strong GMP knowledge and previous experience within sterile filling operations.

Key Responsibilities

• Provide Quality oversight and direction for the start-up, technical transfer, operation and continuous improvement of sterile drug product filling operations.
• Provide QA input to Change Controls, protocols and reports, ensuring activities are clearly defined, compliant and completed within agreed timelines.
• Write, review and approve GMP documentation including SOPs, Work Instructions, Quality Technical Agreements, Master Batch Records and Specifications.
• Work as part of cross-functional project teams to resolve Quality issues and support achievement of project timelines.
• Provide Quality guidance and oversight for lot release activities, including components, raw materials and drug product.
• Compile and review Lot Release Packs in accordance with relevant procedures.
• Review and approve Deviations, investigations and CAPAs, ensuring appropriate root cause analysis and effective corrective and preventative actions.
• Identify potential Quality and compliance risks and ensure issues are appropriately addressed and escalated.
• Support and lead root cause analysis and problem-solving activities for complex Quality issues.
• Promote a strong Quality and cGMP culture across Project and Sterile Filling teams.
• Lead Area GMP Certification activities.
• Support regulatory inspection readiness and activities required to obtain regulatory approvals.
• Provide Quality Assurance support for new product introductions and launches.
• Identify opportunities for continuous improvement across Quality processes and operations.

Qualifications & Experience

• Degree or third-level qualification in Science, Quality or a related discipline.
• Minimum 5+ years’ experience within a Quality function in the pharmaceutical or biotechnology industry.
• Demonstrated experience within Sterile Drug Product Filling, ideally including start-up or new facility operations.
• Strong working knowledge of cGMP, FDA and EMEA regulatory requirements and Quality Systems.
• Experience with Deviations, CAPAs, Change Controls, investigations and GMP documentation.
• Strong problem-solving skills, including experience managing Root Cause Analysis and Non-Conformance/Deviation investigations.
• Ability to work independently while also operating effectively within cross-functional teams.
• Strong organisational skills with the ability to prioritise and manage multiple activities to completion.
• Strong decision-making capability and willingness to take ownership and accountability.
• Excellent written and verbal communication skills.
• Strong stakeholder management and coaching skills.
• Proficiency in Microsoft Office, including Excel, Word and PowerPoint.