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Mandy Irwin

Audit Manager, Craigavon

Almac Pharmaceutical Development, Almac Commercial Services

 

Current Role

In her role as Audit Manager, Mandy is responsible for the management of client audits and support regulatory inspections, primarily at our Craigavon site and at times, our Dundalk site. Her key responsibilities involve supporting the audit coordinator by managing customer audits schedules, liaising with the business to understand the scope of work involved with each audit, and hosting the client for the duration of the audit, ensuring a positive and efficient experience.  

She has recently been appointed the responsibility for management of the Almac Pharma Services Craigavon internal audit schedule.

Experience

With extensive experience in Quality Compliance roles as an Officer and Senior Officer, Mandy has managed various quality functions, including approving process and documentation changes, leading investigations and root cause analysis, ensuring Annex 11 and Part 11 Compliance, conducting internal and vendor audits, and delivering quality metric data. 

As an experienced Audit Manager, she has hosted over 200 customer audits across 2 Almac Pharma Services sites to help secure new business and to ensure continued business with long standing clients ranging from small Pharma and virtual companies to Big Pharma companies. She has also supported over 20 regulatory inspections by a number of Health Authorities, including the MHRA, FDA, HPRA, EAEU Health Authorities, Turkish Ministry of Health, ANVISA and INVIMA (both front room and backroom roles).

Joined Almac

2011

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