QA NPI Specialist - Pharma Quality & New Product Intro

PE Global; Dublin; On-site; EUR 70,000 - 95,000; Full time

Job summary

PE Global is recruiting for a QA NPI Specialist for a leading pharmaceutical company in Dublin on a 12-month contract. You will deliver QA activities to ensure new products are introduced and manufactured to cGMP standards, partnering with Manufacturing, QC, QPs and Technical Services to secure patient supply.

The role requires a minimum of 5 years in a cGMP quality environment, strong knowledge of regulatory expectations (EU/FDA) and experience with QA documentation, audits and CAPA processes.

Qualifications

• Third level qualification e.g. B.Sc. in science/pharmacy.
• Minimum of 5 years’ experience in cGMP Quality environment.
• Strong knowledge of cGMP requirements for pharmaceutical manufacturing.

Responsibilities

• Quality Oversight on new product introduction in Bulk Drug Substance facility.
• Site QA responsibility to provide technical expertise for QA and compliance topics.
• Review and approve validation documents for equipment, software and qualifications.
• Support deviation investigations and CAPA proposals.

Skills

Quality Assurance

cGMP

Regulatory compliance

Auditing

CAPA

Documentation

Veeva Vault

Delta-V

Education

B.Sc. in science/pharmacy

Tools

Delta-V

Veeva Vault

Job description

PE Global is recruiting for a QA NPI Specialist for a leading pharmaceutical company in Dublin on a 12-month contract. You will deliver QA activities to ensure new products are introduced and manufactured to cGMP standards, partnering with Manufacturing, QC, QPs and Technical Services to secure patient supply.

The role requires a minimum of 5 years in a cGMP quality environment, strong knowledge of regulatory expectations (EU/FDA) and experience with QA documentation, audits and CAPA processes.