QA Associate

Fastnet; Cork; On-site; EUR 52,000 - 70,000; Full time

Job summary

Fastnet in Cork, Ireland is seeking an experienced QA Associate on a 12-month contract to support sterile drug product filling operations startup and ongoing QA activities.

The role requires a Degree in Science or related discipline and at least 5 years in a Quality function within pharma/biotech, with sterile filling experience. Strong knowledge of cGMP, FDA/EMEA and CAPA/Deviations is essential.

Qualifications

• 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.

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.

Skills

Quality Assurance

cGMP

CAPA handling

Deviations investigations

Change Controls

Root Cause Analysis

Documentation - GMP

Cross-functional collaboration

Education

Degree in Science or related discipline

Job description

Please note: This is a shift-based position.

Our client is seeking an experienced QA Associate to join its Quality team on a 12-month contract.

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.

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.