About CPi Biotech and the job
CPi Biotech is a highly successful and rapidly expanding Irish-owned Biopharma Engineering Company based in Cork. We are a leading manufacturer of single-use technologies (SUTs) for the biopharmaceutical sector, specialising in single-use assemblies and bioprocessing skid systems. We design and manufacture SUTs for global biopharma and have an international client base in Ireland, Europe, and North America.
We are looking to recruit a Senior Quality Specialist to join our expanding team. The position is permanent and is site-based in our Headquarters, in Little Island, Cork. The vacancy comes at a crucial stage in the company's continued growth; the successful candidate will play a key role in the continued and future growth of the company going forward.
About the Role
Reporting to the Quality Lead, this position requires an effective collaborator to work cross‑functionally and as part of a team. With a strong focus on supplier and customer management, this role will facilitate continuing compliance with the QMS. Working in an ISO‑certified environment, CPi endeavours to excel by also matching cGXP guidelines through shared ownership and execution of the QMS. This role is key to maintaining the quality and safety of products for the bio/pharmaceutical market, ensuring the company meets the specification requirements of its multinational customers, and assuring the security of the supply chain and the company's interests.
Key Responsibilities
Investigation and documentation of non‑conformances
Drafting and timely execution of actions for Change Control and CAPA
Update of key tracking tools for QMS
Batch Record Review and material release (including CoA) to ensure compliance with GMP requirements
QA Review and Approval of SOPs, Work Instructions, and Forms
Supplier approvals process
Customer, supply chain notification activities
Execution of internal and external audits
Product release activities
Continuous improvement initiatives
Contribution to improving KPI metrics
Experience & Qualifications
3-5 years + in a Quality function in a GMP/regulated environment
Bio/Pharmaceutical, Medical Device, Nutraceutical, or Food Science background
Graduate with a scientific degree or qualifications in science, engineering, or technology
Direct exposure to customer/regulatory audits
Prior experience of system ownership
Benefits
Competitive salary and benefits package
Opportunities for career advancement in a rapidly expanding company.
A dynamic, supportive work environment with a focus on professional growth
If you're a self‑motivated, detail‑oriented individual with a desire to contribute to the growth of an innovative Irish biotech company, we encourage you to apply today.
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