QA Operations Specialist

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

Take Your Pharmaceutical Quality Career to the Next Level

QA Operations Specialist

This is your opportunity to join a highly regulated biopharmaceutical environment in Dunboyne , supporting material and product release, quality systems and GMP compliance across site operations.

You'll work across a broad range of QA Operations activities , including batch documentation review, deviations, CAPAs, change controls and product or material release, while working closely with Manufacturing, Engineering, MS&T, Supply Chain and Quality teams.

If you're a QA Specialist, Quality Specialist, QA Operations Specialist, Quality Assurance Specialist or Quality professional with pharmaceutical GMP experience, this role offers the opportunity to build your expertise across a diverse quality environment.

What you'll be working on

• Support the release of incoming materials and outsourced products .
• Review documentation to ensure compliance with GMP, quality procedures and market requirements .
• Support batch record and documentation review .
• Contribute to deviations, CAPAs and change controls .
• Apply strong Good Documentation Practices .
• Communicate quality requirements to suppliers and internal stakeholders.
• Support quality oversight across clinical and commercial operations.
• Work closely with Manufacturing, Engineering, MS&T, Supply Chain and Quality teams.
• 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.

What will make you stand out

You'll ideally bring:

• Pharmaceutical experience - essential .
• Experience working within a GMP/cGMP environment .
• A good understanding of pharmaceutical quality requirements .
• Experience with batch record review and deviation investigations .
• Knowledge of CAPAs, change controls and product/material release .
• Experience working with quality management systems .
• Strong documentation and record-keeping skills.
• Excellent communication and organisational skills.
• Strong problem-solving and troubleshooting abilities.
• The ability to work independently and appropriately escal...
• A relevant Science, Pharmacy or equivalent qualification is advantageous.

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Your personal data will never be shared outside our organisation without your prior written consent.

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