QA Operations Specialist — Biotech/Pharma (11-Month Contract)

PSC Biotech® Corporation; Dunboyne; On-site; EUR 50,000 - 75,000; Full time

Job summary

PSC Biotech Corporation seeks a QA Operations Specialist to support clinical and commercial operations at our Ireland facility. The role focuses on batch record review and release, ensuring strict adherence to cGMP and regulatory requirements.

You will work with site teams to resolve issues, maintain QA systems, and drive continuous improvement in quality, EHS, and training. This is an 11-month contract offering exposure to top pharmaceutical clients.

Qualifications

• Degree or post-graduate qualification in Science, Pharmacy or equivalent.

Responsibilities

• Provide QA oversight to clinical and commercial operations at the facility including quality control, supply chain, engineering and manufacturing.
• Support process technical transfers and analytical transfers, drug substance disposition and regulatory approvals.
• Maintain QA systems (CAPAs, Change Controls, Deviations, Batch Documentation).
• Liaise with internal partners to support daily operations and ensure on-time disposition of commercial Drug Substance.
• Ensure adherence to domestic and international GMP regulations and company policies.
• Represent Quality on multidisciplinary teams and drive continuous improvement.

Skills

QA oversight

Batch record review

cGMP compliance

Problem solving

Team collaboration

Regulatory knowledge

Documentation

Education

Degree in Science/Pharmacy

Job description

PSC Biotech Corporation seeks a QA Operations Specialist to support clinical and commercial operations at our Ireland facility. The role focuses on batch record review and release, ensuring strict adherence to cGMP and regulatory requirements.

You will work with site teams to resolve issues, maintain QA systems, and drive continuous improvement in quality, EHS, and training. This is an 11-month contract offering exposure to top pharmaceutical clients.