A leading global manufacturer of pharmaceutical products with R&D, manufacturing and distribution capabilities worldwide and has its global headquarters in Dublin, Ireland is looking to bring an experienced Qualified Person to the quality team reporting to the EU Head of Quality.

The Role

This exciting contract, part time role will be responsible for the day-to-day QP certification of Products manufactured by or imported by the organisation.

Duties and responsibilities of the Qualified Person will include:

• Act as Qualified Person on behalf of the company - responsible for the review of batch manufacturing records, process deviations, LIRs and disposition of the same.
• Provide QA support for EU importation of pharmaceutical products, and batch release for the EU Market.
• Preparation and execution of Risk Assessments
• Investigation and review of OOS validation results. Reporting of all investigations in line with procedures.
• 100% Participation in Regulatory and Customer Audits. Ensure a state of constant readiness for unannounced regulatory inspections. Produce reports on the audits and ensure that appropriate CAPAs are implemented where necessary.
• Performance of Internal and External Audits (including agenda preparation, report writing and CAPA close out)

The Person

In order to be considered for this exciting daily rate Qualified Person role, specific requirements for the successful candidate would include:

• Qualified to Minimum of a Bachelor's degree (Level 8 NFQ) in Chemistry, Biology, Pharmacy or relevant technical discipline (e.g. Engineering, Technical)
• MSc / Postgraduate Diploma in Pharmaceutical Manufacturing Technology or other related QP qualification
• 5+ years' relevant experience within the quality assurance / quality control / compliance functions of the pharmaceutical industry.
• Eligible to act as Qualified Person releasing product into the Irish and European Markets

What's on offer:

• Exciting long-term daily rate contract role within a leading global pharmaceutical company
• Opportunity to work within a global leader giving you access to build your portfolio within the medical device industry
• Potential for a long term opportunity within the organisation

To discover more about this opportunity, apply now or contact Laura Gallagher at HRM on +353 91 782 113 for a confidential discussion.