QA Associate

QCS Staffing; Cork; On-site; EUR 42,000 - 54,000; Full time

Job summary

QCS Staffing seeks a QA Associate in Cork, Ireland, on an initial 12-month contract with a world-leading biopharmaceutical company focused on sterile drug product filling and quality systems. You will provide quality direction for start-up, transfer, operation and continuous improvement of sterile filling, support change controls and SOPs, and collaborate across functions to maintain GMP compliance.

The ideal candidate holds a degree in science or quality, with experience in sterile product

Qualifications

• Degree or 3rd level qualification (Science, Quality). QP Qualification would be an advantage.
• Demonstrated experience in Sterile Drug Product Filling and start-up of same.
• Experience in a Quality function in pharma/biotech with GMP awareness.
• Solid knowledge of FDA/EMEA regulations and quality systems.

Responsibilities

• Provide Quality direction and oversight of start-up, transfer, operation, and continuous improvement of Sterile Drug Product Filling operations.
• Provide Quality input to Change Controls, Protocols and Reports ensuring clear scope and timely implementation.
• Write, review and approve SOPs, Work Instructions, QTA, Master Batch Records and other GMP documentation.
• Collaborate across inter-departmental teams to address issues in real time and support project timelines.

Skills

Sterile Drug Product Filling

Quality systems knowledge

FDA/EMEA regulations

Biopharmaceutical quality

Education

Degree in Science/Quality

Job description

QA Associate – Ireland, Cork – Initial 12- Month Contract – Life Sciences

Are you interested in joining a world leading biopharmaceutical company, focused on developing advanced and innovative treatments for those suffering with rare diseases?

This is a fantastic opportunity to work in a state-of-the-art facility in Cork. You will be joining a leading Biopharmaceutical company who focus on a range of products which are life-changing for individuals.

Our client is currently seeking a QA Associate.

What You’ll Deliver

• Provide Quality direction and oversight of the start-up, technical transfer, operation, and continuous improvement of Sterile Drug Product Filling operations.
• Provide Quality input to Change Controls, Protocols and Reports ensuring scope of records are clear and implementation activities are robust and timely.
• Write, review and approve Standard Operating Procedures, Work Instructions, Quality Technical Agreements, Master Batch Records, Specifications and other GMP documentation in accordance with company policies.
• Participates within inter-departmental and cross-functional project teams to immediately address issues and questions in real time to help ensure project timelines are achieved.

What you’ll need:

• Degree or 3rd level qualification (Science, Quality). QP Qualification would be an advantage.
• Demonstrated experience in Sterile Drug Product Filling and start-up of same.
• Relevant experience working in a Quality function in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the other requirements of the role.
• Demonstrates good knowledge of FDA / EMEA regulations/standards and quality systems.