QA Compliance & Systems Specialist

Are you ready to contribute to the success of a state-of-the-art commercial drug product manufacturing facility? We're looking for a QA Specialist to join our team and support material qualification and release activities for an innovative biologics portfolio and clinical pipeline.

Key Responsibilities:

As a QA Specialist, you will:

• Prepare, review, and approve material qualification documentation.
• Oversee QA disposition of raw materials and consumables.
• Author, review, and approve QA-related procedures.
• Perform QA review, assessment, and approval activities for biologics manufacturing, including:
• Change controls
• Deviations and investigations
• Supplier investigations
• Corrective and Preventive Actions (CAPAs)
• Supplier change notifications (SCNs)
• TSE certificates and other relevant documentation
• Be an integral member of the QA Compliance Materials Management team.
• Support operational excellence initiatives, such as 5S, standard work, Kaizen, and problem-solving.

Qualifications & Experience:

To thrive in this role, you should have:

• A BSc in Science or a related discipline with QA or relevant experience in a biologics or pharmaceutical environment.
• A solid understanding of cGMP requirements for manufacturing systems and compliance.
• Knowledge of material qualification and SAP (a plus but not required).
• Strong communication and presentation skills.
• Proven time management and organizational abilities, with a knack for multitasking.
• The ability to work both independently and collaboratively within a matrixed team structure to meet accelerated timelines.

This role offers an exciting opportunity to make a tangible impact in biologics manufacturing while fostering your professional growth.

The Next Step for you:

Should this position be of interest to you please submit your CV to Barry O'Mahony from Next Generation Recruitment using the apply button.

Next Generation are specialists in Supply Chain, Procurement, Engineering, Quality, Technical and Operation (permanent, contract and temporary) positions.

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