In-Process Quality Assurance Associate

R&D Partners; Munster; On-site; EUR 42,000 - 64,000; Full time

Job summary

R&D Partners in Ireland is seeking a Quality Assurance Associate to provide quality support to Production and Warehouse activities, ensuring GMP-compliant batch records, in-process checks, sampling, and documentation review.

The role is fully on-site with shift-based duties, requiring the right to work in Ireland and strong attention to detail in regulated manufacturing environments.

Qualifications

• Science graduate with minimum 3 years experience in Pharmaceutical GMP environment accredited with HPRA and FDA.
• Post graduate qualification in Pharmaceutical area is also acceptable.

Responsibilities

• Support batch manufacture including line sign-off prior to start of batch manufacture, performing in process checks.
• Review batch records, logbooks, forms, protocols, reports and COAs for accuracy and compliance.
• Real-time monitoring of manufacturing, packing and cleaning operations and documentation for SOPs and GMP.
• Review of SOPs for manufacturing operations and cleaning.
• Participate in investigations related to manufacturing and prepare SOPs, investigations, reports and forms.
• Support training activities and on-the-job training; assist Warehouse activities as required.
• Support audits by regulatory authorities and customers as required.

Skills

GMP knowledge

Documentation skills

Communication

Problem solving

Education

Science graduate

Post graduate qualification in pharmaceutical area

Job description

Looking to uncover quality insights that could revolutionize the future of medicine and drive breakthroughs in patient care?

R&D Partners is seeking a Quality Assurance Associate to 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 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 yearexperience 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