Sr QA Associate

PE Global; Dublin; On-site; EUR 55,000 - 75,000; Full time

Job summary

PE Global is recruiting a Plant QA Specialist for a 12-month contract based at our Bio site in South Dublin. The 24/7 shift pattern supports manufacturing operations, with a focus on quality oversight and compliance across vial, syringe, and aseptic processes.

The Senior Associate will review batch records, support deviations and investigations, and provide training and QA guidance to staff while ensuring cGMP and regulatory adherence.

Qualifications

• Strong written and verbal communication skills.
• Experience collaborating with cross-functional teams.
• Familiarity with applicable regulatory requirements.
• Experience in aseptic operations and QA reviews.
• Ability to inspect records and ensure compliance.

Responsibilities

• Provide real-time QA oversight for manufacturing and inspection activities.
• Review and approve production batch records for disposition.
• Support formulation, fill finish, media fills, and aseptic interventions.
• Inspect vials and syringes and participate in AQLs and investigations.
• Offer QA support for on-the-floor deviations and investigations.
• Review and close deviations with proper documentation.
• Participate in customer complaint investigations.
• Conduct routine QA walks and train staff on procedures.

Skills

Communication skills

Cross-functional collaboration

Organizational skills

Problem-solving

Regulatory knowledge

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***