Senior QA Specialist – 12h Plant Shifts

PE Global (UK); Ireland; Sur place; EUR 65 000 - 95 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Clear communication

Cross-functional collaboration

Problem solving

QA documentation

Aseptic operations

Regulatory compliance

Formation

University degree in Engineering or Science-related discipline

Description du poste

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