Biotech QA Operations Specialist - GMP, CAPAs & CI

PSC Biotech® Corporation; Dunboyne; On-site; EUR 65,000 - 80,000; Full time

Job summary

PSC Biotech is hiring a QA Operations Specialist for a 11-month maternity cover in our Ireland facility. The role supports the QA Operations Self Directed Work Team, ensuring cGMP compliance, quality system deployment, and regulatory submissions readiness.

You will work with Manufacturing Ops, PD-TS, and Engineering to sustain quality and continuous improvement. Ideal candidates will have a Science or Pharmacy degree with 4+ years of QA experience, strong knowledge of QMS, audits, and

Qualifications

• 4+ years experience in QA.
• Knowledge of Quality Management System tools and processes.
• Experience in internal and external audits.
• Strong analytical and problem-solving skills.

Responsibilities

• Review batch records, deviations, CAPAs and investigations.
• Support regulatory readiness and quality oversight of manufacturing operations.
• Coordinate with cross-functional teams to ensure compliance with cGMP/regulations.
• Participate in continuous improvement and quality system deployment across the site.
• Provide QA support for qualification/validation activities and tech transfers.

Skills

QA experience

Regulatory knowledge

Quality systems

Analytical skills

Education

Science/Pharmacy degree

Job description

PSC Biotech is hiring a QA Operations Specialist for a 11-month maternity cover in our Ireland facility. The role supports the QA Operations Self Directed Work Team, ensuring cGMP compliance, quality system deployment, and regulatory submissions readiness.

You will work with Manufacturing Ops, PD-TS, and Engineering to sustain quality and continuous improvement. Ideal candidates will have a Science or Pharmacy degree with 4+ years of QA experience, strong knowledge of QMS, audits, and