Sr QA Associate – Dublin

PE Global (UK); Ireland; On-site; EUR 65,000 - 95,000; Full time

Job summary

PE Global are recruiting for a Plant QA Specialist – Senior Associate based at our Bio client site in South Dublin on a 12-month contract. You will report to the QA Manager and act as the quality focal point for manufacturing and inspection operations, contributing to continuous improvement beyond routine QA duties.

The 24/7 role uses a 12-hour shift pattern (4 on, 4 off) to support manufacturing. You will review batch records, oversee aseptic activities, investigations, deviations, and cGMP

Qualifications

• 4+ years of relevant pharmaceutical or biotechnology experience.
• University degree in engineering or science.
• Strong communication and collaboration with cross-functional teams.

Responsibilities

• Ensure adherence to safety standards and SOPs.
• Review and approve production batch records for Qualified Person disposition.
• Provide real-time quality oversight for formulation, vial and syringe Fill Finish activities.
• Conduct inspections of vials and syringes as part of AQLs and investigations.
• Offer QA support for on-the-floor investigations and deviations.
• Review and approve deviations for closure with proper documentation.
• Participate in customer complaint investigations.
• Conduct routine QA walks on the production floor.
• Review and issue logbooks for compliance.
• Provide training and guidance to staff on quality practices.
• Review and approve cGMP records and documentation.
• Support continuous improvement and Operational Excellence initiatives.

Skills

Clear communication

Cross-functional collaboration

Problem solving

QA documentation

Aseptic operations

Regulatory compliance

Education

University degree in Engineering or Science-related discipline

Job description

PE Global are currently recruiting for a Plant QA Specialist – role to be based in our Bio client site in South Dublin on a 12 month initial contract: 24/7 shift role

Job Overview:

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 Qualifications & Experience:

• Exceptional written and verbal communication skills.
• Proven experience collaborating with dynamic cross-functional teams and strong decision-making abilities.
• Robust organizational skills, with a commitment to seeing assignments through to completion.
• Demonstrated problem-solving abilities, particularly in supporting non-conformance/deviation investigations.
• Experience in inspecting vials and syringes and engaging in aseptic operations.
• Familiarity with applicable Regulatory requirements and proficiency in evaluating compliance issues.

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.

Basic Qualifications & 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.

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***