Pharma QA Operations Specialist: GMP & Release

Next Generation Recruitment; Dunboyne; On-site; EUR 50,000 - 70,000; Full time

Job summary

Next Generation Recruitment is seeking a QA Operations Specialist to join a highly regulated biopharmaceutical environment in Dunboyne. You will support material and product release, quality systems and GMP compliance across site operations.

Responsibilities include batch documentation review, deviations, CAPAs, change controls and product release while collaborating with Manufacturing, Engineering, MS&T, Supply Chain and Quality teams.

Qualifications

• Pharmaceutical GMP experience is essential.
• Experience in GMP/cGMP environments.
• Understanding of pharmaceutical quality requirements.
• Experience with batch record reviews and deviation investigations.
• Knowledge of CAPAs, change controls and product/material release.
• Experience with quality management systems.
• Strong documentation and record-keeping.
• Excellent communication and organisational skills.
• Ability to work independently and escalate when required.
• Science, Pharmacy or equivalent qualification is advantageous.

Responsibilities

• Support the release of incoming materials and outsourced products.
• Review documentation to ensure GMP compliance.
• Support batch record reviews.
• Contribute to deviations, CAPAs and change controls.
• Apply Good Documentation Practices.
• Communicate quality requirements to suppliers and internal stakeholders.
• Support quality oversight across clinical and commercial operations.
• Collaborate with Manufacturing, Engineering, MS&T, Supply Chain and Quality.
• Escalate quality issues and support their resolution.
• Contribute to continuous improvement and quality system activities.
• Represent Quality within multidisciplinary teams.
• Work independently while contributing effectively within a wider team.

Skills

GMP

cGMP

Batch review

Deviation investigations

CAPAs

Change controls

Documentation

Quality oversight

Supplier quality communication

Quality systems

Independent work

Education

Science or Pharmacy degree

Job description

Next Generation Recruitment is seeking a QA Operations Specialist to join a highly regulated biopharmaceutical environment in Dunboyne. You will support material and product release, quality systems and GMP compliance across site operations.

Responsibilities include batch documentation review, deviations, CAPAs, change controls and product release while collaborating with Manufacturing, Engineering, MS&T, Supply Chain and Quality teams.