QA Specialist - New Facility Launch (GMP)

Ipsen Group; Wrexham; On-site; GBP 35,000 - GBP 55,000; Full time

Job summary

A leading biopharmaceutical company in Wrexham is looking for a QA Specialist to oversee documentation and processes for a new drug product facility. This role involves ensuring compliance with GMP standards, leading investigations, and delivering training. The ideal candidate has experience in pharma or biopharma, with strong knowledge of validation and regulatory requirements. Join a committed team focused on innovation and excellence.

Qualifications

• Experience in a similar role in pharma or biopharma.
• Strong knowledge of GMP, validation, and regulatory requirements.
• Experience in sterile manufacturing environments is highly preferred.

Responsibilities

• Provide QA oversight for documentation and processes during facility set-up.
• Support batch record review and ensure timely, compliant batch release.
• Lead investigations into deviations, OOS, CAPAs, and change controls.
• Deliver training and guidance on GMP and quality standards.
• Drive continuous improvement and promote a proactive quality culture.

Skills

Experience in a similar role in pharma or biopharma

Strong knowledge of GMP, validation, and regulatory requirements

Experience in sterile manufacturing environments

Job description

A leading biopharmaceutical company in Wrexham is looking for a QA Specialist to oversee documentation and processes for a new drug product facility. This role involves ensuring compliance with GMP standards, leading investigations, and delivering training. The ideal candidate has experience in pharma or biopharma, with strong knowledge of validation and regulatory requirements. Join a committed team focused on innovation and excellence.