QA Operations Specialist – cGMP & Batch Release

PSC Biotech Corporation; Dunboyne; On-site; EUR 56,000 - 84,000; Full time

Job summary

PSC Biotech Corporation in Ireland seeks a QA Operations Specialist for a single-use multi-product biotech facility. The role supports clinical and commercial operations, including batch record review and release, across site teams to resolve issues and drive quality and continuous improvement, while ensuring compliance with cGMP and corporate regulations.

The 11-month contract involves collaborating with Manufacturing, MS&T and Engineering, maintaining site quality systems, and driving CAPAs

Qualifications

• Degree or post-graduate qualification in Science, Pharmacy or equivalent.
• Minimum 3 years’ experience in the biotechnology and/or pharmaceutical industry.
• Knowledge of cGMP regulations both domestic and international.

Responsibilities

• Provide QA oversight to clinical and commercial operations at the facility including quality control, supply chain, engineering and manufacturing and support process technical transfers.
• Support execution of an effective Quality system and quality management systems (CAPAs, Change Controls, Deviations, Batch Documentation Review).
• Liaises with internal partners in support of daily operations.
• Coordinate with peer Quality groups to ensure on-time disposition of commercial Drug Substance.

Skills

Biotech/Pharma exp

cGMP knowledge

Quality management

Problem solving

Teamwork

Education

Science/Pharmacy degree

Job description

PSC Biotech Corporation in Ireland seeks a QA Operations Specialist for a single-use multi-product biotech facility. The role supports clinical and commercial operations, including batch record review and release, across site teams to resolve issues and drive quality and continuous improvement, while ensuring compliance with cGMP and corporate regulations.

The 11-month contract involves collaborating with Manufacturing, MS&T and Engineering, maintaining site quality systems, and driving CAPAs