QA Operations Specialist – Biotech GMP & Compliance

PSC Biotech Corporation; Dunboyne; On-site; EUR 55,000 - 75,000; Full time

Job summary

PSC Biotech Corporation invites applications for a QA Operations Specialist to support clinical and commercial operations at a single-use, multi-product biotech facility in Ireland. You will drive quality systems, compliance, and continuous improvement across site teams.

Requirements include a Science or Pharmacy degree and a minimum of 3 years’ experience in biotechnology/pharmaceutical industries, plus experience with deviation management and Change Controls, and strong knowledge of cGMPs.

Qualifications

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

Responsibilities

• Provide QA oversight to the clinical and commercial operations at the facility including quality control, supply chain, engineering and manufacturing support, and regulatory approvals.
• Responsible for supporting execution of an effective Quality system and accountable for quality oversight of quality management systems (CAPAs, Change Controls, Deviations, Batch Documentation Review).
• Liaises with internal partners to support daily operations.
• Coordinate with peer Quality groups to ensure on-time disposition of commercial Drug Substance.
• Ensures clear communication on issues and timely escalation as applicable.
• Helps maintain site practices and procedures related to clinical and commercial operations.
• Adheres to domestic and international GMP regulations and company policies.
• Champion site metrics to ensure targets are achieved and counter measures are in place when applicable.

Skills

Deviation management

Change controls

Batch Record Review

cGMP knowledge

Problem solving

Decision making

Teamwork

Pressure handling

Education

Science or Pharmacy degree

Post-graduate qualification

Job description

PSC Biotech Corporation invites applications for a QA Operations Specialist to support clinical and commercial operations at a single-use, multi-product biotech facility in Ireland. You will drive quality systems, compliance, and continuous improvement across site teams.

Requirements include a Science or Pharmacy degree and a minimum of 3 years’ experience in biotechnology/pharmaceutical industries, plus experience with deviation management and Change Controls, and strong knowledge of cGMPs.