Quality Auditor

3 weeks ago

Sligo, Ireland FRS Recruitment Full time

Our client is a global life-science innovator scaling new platforms in vaccines / biologics. They are on a growth curve and are currently recruiting a QA professional to take ownership of global supplier qualification and oversight.

This is a genuinely strategic role — you won’t just execute audits; you will shape how supplier risk is modelled, qualified, monitored and governed across multiple GxP domains.

Duties

- Design and continually improve the supplier qualification framework across GMP + one or more of: GLP / GCP / GDP

- Lead onsite and remote audits (initial / routine / for-cause) and drive effective CAPA close-out

- Review / sign-off on tech quality agreements, change notifications, deviations, audit responses

- Feed QA risk intelligence into procurement, sourcing strategy and outsourcing decisions

- Provide QA input into investigations tied to third-party data / product / service issues

- Train the wider organisation on expectations for external partner governance

- Be the QA voice in cross-functional teams on outsourced R&D / testing / manufacturing

- Keep audit trails, supplier status, classification and evidence tight & clean in the eQMS

Requirements

- Degree in a biological / pharma science discipline

- 6-7 years QA experience in pharma / biologics / vaccines

- 4-5 years hands-on auditing and supplier qualification experience

- Deep GMP know-how, plus strong exposure to at least one of GLP / GCP / GDP

- Can run complex external audits solo — cradle to grave

- Strong with CAPA, change control, agreements & risk methodology

- Comfort with eQMS and digital supplier tracking platforms

- Confident communicator who can influence procurement, R&D, QC, Regulatory and Ops

Additional languages is a plus

Interested?

For a confidential discussion, please reach out with your CV -demonstrating your strong hands-on auditing and supplier qualification experience.

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