QP

Job Description

I am delighted to bring an exciting opportunity to market for a QP with a pharmaceutical company based in Dublin. This is a FTC with flexible working of 2+ days a week.

In this role you will be responsible for day-to-day QP certification of products manufactured or imported in line with Directive 2001/83/C as amended by Directive 2004/27/EC and in Annex 16 EU guidelines in line with GMP. If you are QP eligible seeking an opportunity to get on a license this could be the role for you.

For this role you will have a degree in chemistry, biology or pharmacy and ideally have 3-5 years' experience within QA, QC or compliance coming from the pharmaceuticals industry. You must be eligible to function as a QP releasing product to Irish and EU markets. Experience in leading and supporting GMP audits including drug product manufacturing and analytical testing.

Responsibilities:

• Function as a QP responsible for review of batch manufacturing records, process deviations, LIRs and disposition in line with EU guidelines.
• Provide QA support for EU importation of pharmaceutical products and batch release for the EU market.
• Preparation and execution of risk assessments.
• Investigations and review of OOS validation results and reporting all investigations.
• Participation in regulatory and customer audits ensuring a state of audit readiness for regulatory inspections.
• Reporting on audits and ensuring CAPAs are implemented.
• Review of PQRs.
• Review and assessment of change controls.
• Preparing and updating technical agreements, SOPs, and specifications.
• Conduct GMP training and other trainings as needed.

If this role is of interest, please 'apply now.'

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

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