Senior Qa Specialist (extended Days)

Trzdev35

College Park, Dublin
Cgmp oversight
Quality management system
Regulatory and gmp requirements
Provide advanced quality oversight for our Bulk Drug Substance (BDS) facility at ADMF, ensuring manufacturing, testing, labelling, and storage activities meet all regulatory and GMP requirements

Job Summary

  • Provide advanced quality oversight for our Bulk Drug Substance (BDS) facility at ADMF, ensuring manufacturing, testing, labelling, and storage activities meet all regulatory and GMP requirements.
  • Partner closely with Operations, QC, Engineering, Facilities, Supply Chain and QPs to maintain compliance, support inspection readiness, and ensure uninterrupted patient supply.
  • Step into a senior QA role where your expertise directly safeguards the quality, safety, and availability of life‑changing biologic medicines, all within a high‑performing team that values ownership, collaboration, and continuous improvement.

Matching Summary

Provide advanced quality oversight for our Bulk Drug Substance (BDS) facility at ADMF, ensuring manufacturing, testing, labelling, and storage activities meet all regulatory and GMP requirements.

Skills & Requirements

Must-have

  • cGMP oversight
  • Quality Management System
  • regulatory and GMP requirements
  • health authority inspectors
  • shift-based position

Nice-to-have

  • Lean or Six Sigma environment
  • collaboration, and continuous improvement
  • ownership
  • international matrix environment

Key Requirements

  • Degree in Pharmacy, Biology, Biotechnology, Engineering, or relevant scientific discipline
  • Significant experience in a biologics quality function
  • Proficiency with SAP, EDMS, and MES systems
  • Fluency in written and spoken English

Work Rights

Not specified

Tailored Resume

Cover Letter