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Stephen Boles

Quality Compliance Manager, Craigavon

Almac Pharmaceutical Development, Almac Commercial Services

 

Current Role

In his role as Quality Compliance Manager, Stephen is responsible for Quality Compliance and Audit Management at Craigavon. This involves the management and governance of the Pharmaceutical Quality System (PQS), ensuring quality standards and regulatory expectations are developed and maintained. The audit element of his role involves the efficient and timely management of the Craigavon internal audit schedule, external client audits and regulatory inspections.

Experience

Stephen began his career at Almac Clinical Services as a project coordinator, then moved to the Validation department at Almac Pharma Services. He was fortunate to be involved in the qualification of new facilities, utilities, equipment, systems, and processes, supporting the division’s expansion. 

After 9 years, Stephen transitioned to Quality Assurance, handling tasks like training personnel, generating and approving GxP documentation, reviewing batch records, improving processes, leading inspections, and supporting product launches. 

Now, as the Quality Compliance Manager at our global headquarters in Craigavon, Stephen manages and supports the PQS, ensuring high GxP standards are maintained.

Joined Almac

2004

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