QA Operations Specialist - 11-Month Maternity Cover

PSC Biotech Corporation; Dunboyne; On-site; EUR 65,000 - 90,000; Full time

Job summary

PSC Biotech Corporation in Ireland seeks a QA Operations Specialist for a 11-month maternity cover contract. The role focuses on QA oversight, documentation, CAPA investigations and regulatory readiness at a state-of-the-art biotech facility. You will collaborate across Manufacturing, PD-TS and Engineering to uphold quality and compliance.

Required: degree in Science/Pharmacy and 4+ years QA experience, strong GMP knowledge, and excellent communication. Multinational environment exposure a plus.

Qualifications

• Bachelor's degree in Science or Pharmacy or equivalent.
• 4+ years of QA experience.
• Strong knowledge of quality management systems and GMP.
• Experience with internal audits and regulatory interactions.
• Excellent written and verbal communication.

Responsibilities

• Reviews and approves batch records, discrepancy reporting, investigations and CAPAs.
• Supports QA oversight of quality management systems and regulatory compliance.
• Coordinates with cross-functional teams to ensure on-time disposition of Drug Substance.
• Provides QA support for regulatory submissions and inspection readiness.
• Maintains site quality practices, procedures and documentation.
• Drives continuous quality improvement using tools like DMAIC/Lean QA.

Skills

QA operations

cGMP knowledge

CAPA & investigations

Regulatory inspections

Quality systems

Education

Bachelor's degree in Science/Pharmacy

Job description

PSC Biotech Corporation in Ireland seeks a QA Operations Specialist for a 11-month maternity cover contract. The role focuses on QA oversight, documentation, CAPA investigations and regulatory readiness at a state-of-the-art biotech facility. You will collaborate across Manufacturing, PD-TS and Engineering to uphold quality and compliance.

Required: degree in Science/Pharmacy and 4+ years QA experience, strong GMP knowledge, and excellent communication. Multinational environment exposure a plus.