Global Quality Systems Specialist

PCI TRGR Penn Pharmaceutical Services Ltd; Killiney; Presencial; EUR 45.000 - 65.000; Jornada completa

Descripción de la vacante

PCI Pharma Services is seeking a Quality Assurance professional to implement and execute day-to-day QA tasks at the City North business unit. The role covers documentation, process controls, and collaboration with cross-functional teams to ensure cGMP compliance.

Responsibilities include writing/reviewing SOPs and forms, handling deviations and CAPAs, preparing QA reports, and supporting audits. Training responsibilities and cross-department involvement are also part of the role.

Formación

• The role is to implement and execute tasks relating to day-to-day Quality Assurance aspects.
• Responsible for executing training for quality & other relevant persons.
• Assist with preparation for customer/regulatory audits.

Responsabilidades

• Ensure safe work practices are followed; report near misses to EHS.
• Write and review SOPs, Work Instructions, BPRs and forms.
• Write and review Deviations, Non-Conformance reports, Corrective Action Requests; prepare final report for QP review.
• Follow up on change control actions and drive for on-time closure.
• Prepare quarterly site reports and Product Quality Review reports.
• Prepare and present monthly/annual metrics.

Descripción del empleo

PCI Pharma Services is seeking a Quality Assurance professional to implement and execute day-to-day QA tasks at the City North business unit. The role covers documentation, process controls, and collaboration with cross-functional teams to ensure cGMP compliance.

Responsibilities include writing/reviewing SOPs and forms, handling deviations and CAPAs, preparing QA reports, and supporting audits. Training responsibilities and cross-department involvement are also part of the role.