QA Specialist II

4 weeks ago

Cork, Cork, Ireland Westbourne IT Global Services Full time

We are seeking a QA Specialist II to join our Quality Assurance team. The ideal candidate will have experience in GMP-regulated environments and be responsible for ensuring compliance with regulatory standards, conducting quality audits, reviewing documentation, and supporting continuous quality improvement initiatives.

Key Responsibilities:
  • Ensure compliance with GMP, FDA, EMA, and other regulatory requirements for manufacturing and laboratory processes.
  • Conduct batch record reviews, deviation investigations, CAPA, and change control assessments.
  • Perform internal audits and support external regulatory inspections.
  • Review and approve Standard Operating Procedures (SOPs), protocols, and validation documents.
  • Support deviation management, root cause analysis (RCA), and corrective/preventive actions (CAPA).
  • Collaborate with cross-functional teams (Production, QC, Engineering) to maintain quality compliance.
  • Ensure proper documentation and data integrity practices are followed in accordance with ALCOA+ principles.
  • Assist in supplier/vendor qualification and audits.
  • Participate in continuous improvement initiatives related to quality and compliance.
  • Train staff on quality standards, procedures, and regulatory compliance.
Requirements:
  • Bachelor's or Master's degree in Life Sciences, Chemistry, Microbiology, Biotechnology, or a related field.
  • 3-5 years of experience in a pharmaceutical, biotech, or medical device QA role.
  • Strong knowledge of GMP, FDA, EMA, and other regulatory guidelines.
  • Experience in handling deviations, CAPA, change control, and batch record reviews.
  • Familiarity with risk assessment, root cause analysis (RCA), and audit preparation.
  • Excellent written and verbal communication skills.
  • Strong attention to detail and ability to work independently.
Preferred Qualifications:
  • Experience with LIMS, TrackWise, or other quality management systems (QMS).
  • Knowledge of data integrity principles (ALCOA+), ISO 9001, and validation processes.
  • Prior experience in biologics, sterile manufacturing, or API production.
  • Certified in Lean Six Sigma, ASQ, or other quality certifications is a plus.

Competitive salary and benefits package.

Opportunities for career growth in a leading pharmaceutical/biotech company.

Dynamic and collaborative work environment.


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