Quality Assurance Specialist

Life Science Recruitment; Leinster; On-site; EUR 70,000 - 95,000; Full time

Job summary

Life Science Recruitment is seeking a Senior Associate for Plant Quality Assurance (PQA) for an award-winning pharmaceutical organization based in Dublin. The role reports to the QA Manager and serves as the QA point of contact for manufacturing and inspection operations during 24/7 production.

The successful candidate will lead on cGMP records, deviations, and investigations, support continuous improvement, and provide training to staff.

Qualifications

• University degree in engineering or science-related discipline.
• 4+ years of experience in pharmaceutical or biotechnology industry.
• Experience supporting non-conformance/deviation investigations.
• Experience inspecting vials/syringes and aseptic operations.

Responsibilities

• Ensure adherence to safety standards and SOPs.
• Review and approve production batch records and disposition activities.
• Provide real-time quality oversight for manufacturing and Fill Finish operations.
• Conduct inspections of vials and syringes; support aseptic activities.
• Support investigations and deviations on the floor and in logbooks.
• Review and approve deviations for closure with proper documentation.
• Participate in customer complaint investigations.
• Provide training and guidance to staff on QA processes.
• Review cGMP records and ensure proper documentation.

Skills

Quality Assurance

GMP compliance

Documentation

Quality inspections

Education

Engineering or Science degree

Job description

We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

The Senior Associate for Plant Quality Assurance (PQA) will report to the QA Manager, playing a pivotal role in the site's Quality Assurance team. As the Quality point of contact for manufacturing and inspection operations, the PQA Senior Associate will contribute to continuous improvement initiatives by undertaking additional responsibilities beyond routine QA duties.

This 24/7 shift role demands a 12-hour shift pattern (4 on, 4 off) to support manufacturing operations.

Key Responsibilities:

• Ensure adherence to safety standards and SOPs in all activities.
• Review and approve production batch records and associated documentation for Qualified Person disposition activities.
• Provide real-time quality oversight and support for production unit operations, extending to formulation, vial and syringe Fill Finish activities, including media fills and assessment of aseptic interventions.
• Conduct inspections of vials and syringes as part of AQLs, annual reserve inspections, and support complaint investigations.
• Offer Quality Assurance support for on-the-floor investigations and deviations.
• Review and approve deviations for closure, ensuring compliance with appropriate documentation.
• Participate in customer complaint investigations.
• Conduct routine Quality Assurance walks on the production floor.
• Review and issue logbooks, ensuring compliance with procedures.
• Provide training and guidance to staff for effective performance.
• Review and approve cGMP records, ensuring compliance with appropriate documentation.
• Support continuous improvement and Operational Excellence initiatives.
• Undertake other tasks/projects as assigned by the manager.

Education and Experience:

• University degree in an Engineering or Science-related discipline (preferred).
• Over 4 years of relevant experience in the pharmaceutical or biotechnology industry or an equivalent combination of experience and educational background.
• Demonstrated problem-solving abilities, particularly in supporting non-conformance/deviation investigations.
• Experience in inspecting vials and syringes and engaging in aseptic operations.