In-Process Quality Assurance Associate

Do you have the eye for detail needed to ensure every pharmaceutical batch meets the highest GMP standards?

R&D Partners is seeking an In-Process Quality Assurance Associate to join our client’s team. In this role, the ideal candidate will provide Quality Support to Production and Warehouse activities including batch record review, in process checks, sampling, documentation review and process audits to ensure batches are manufactured in compliance with regulatory requirements, company policy and procedures. This is a fully on-site shift-based role.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

• Support to batch manufacture including line sign-off prior to start of batch manufacture, performing in process checks during batch manufacture.
• Perform routine reviews of documentation such as Batch records, logbooks, forms, protocols, reports, COAs, etc. generated to support commercial and development batches for accuracy, completeness, and compliance to GMP and procedural requirements.
• Perform real time monitoring of manufacturing, packing, and cleaning operations and documentation for adherence to SOPs and GMP
• Review of Standard Operation Procedures for manufacturing operations and cleaning.
• Participate in any investigations related to manufacturing.
• Prepare Standard Operating Procedures, investigations, reports and forms as required.
• Perform swab sampling (chemical)
• Perform process audits. Monitoring of GMP compliance during production activities
• Monitor documentation errors and work with personnel to correct documentation, as needed, and develop preventive actions to reduce or eliminate recurrences.
• Management of retain samples.
• Sampling and inspection activities.
• Issuance of documentation for production – Batch Record, SOPs etc.
• Support Training activities – preparation / execution of on-the-job training
• Support Warehouse activities as required.
• Support the Head of Quality/Designee during regulatory/customer/corporate audits as required.

Key Skills and Requirements:

• Science Graduate with minimum of 3 year experience in Pharmaceutical GMP environment accredited with HPRA and FDA or Post Graduate Qualification in Pharmaceutical area
• Good communicator both verbally and written
• Strong problems solving skills with knowledge of GMP requirements
• High attention to detail, strong documentation skills
• Must be eligible to work in Ireland

For more information, please contact Billy O’Brien.

If you are interested in applying to this exciting opportunity, then please click ‘Apply’ or to speak to one of our specialists visit the ‘Contact Us’ page.

R&D Partners is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. R&D Partners is acting as an Employment Agency in relation to this vacancy.

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