Pharma Utilities Technician: Quality & Compliance Lead

CareerWise Recruitment; Waterford; Presencial; EUR 55.000 - 75.000; Tempo integral

Resumo da vaga

CareerWise Recruitment is seeking a Utility Technician for a leading pharmaceutical client in Waterford on a 23-month contract. The role covers regulatory compliance, quality oversight, data integrity, and engineering performance for clean utilities systems including WFI, Purified Water, Clean Steam, HVAC, and Compressed Air.

Responsibilities include oversight of IQ/OQ/PQ, audits, CQAs/CPPs, deviations, CAPA, and QMS tasks.

Qualificações

• 3-5 years in pharmaceutical manufacturing with direct clean utilities exposure.
• 3+ years in a GMP quality, engineering, or compliance role.
• Qualification in Engineering (Chemical, Mechanical) or Science (Chemistry, Microbiology, Pharma Sciences).

Responsabilidades

• Ensure clean utilities adhere to cGMP, EU GMP Annex 1, FDA guidelines, and pharmacopeial standards (USP, EP, JP).
• Oversee system qualification, validation, and requalification cycles (IQ/OQ/PQ).
• Coordinate audit/inspection readiness and manage regulatory responses.
• Monitor CQAs/CPPs, microbiological/chemical testing, and OOS/OOT trends.
• Manage QMS tasks including deviations, CAPA, change controls, and ICH Q9.
• Drive root‑cause investigations (5‑Why, Fishbone, FMEA) for failures to minimize process deviations and discards.
• Conduct periodic quality reviews, system risk assessments, and vendor oversight.
• Serve as the ALCOA+ Champion across paper records and automated systems (SCADA, Historians, LIMS, MES).
• Enforce compliance with 21 CFR Part 11 and EU Annex 11.
• Manage system security, user access controls, audit trail reviews, and backup strategies to prevent unauthorized data changes.
• Approve engineering modifications, calibrations, and equipment upgrades.

Conhecimentos

cGMP compliance

Quality oversight

Regulatory compliance

Data integrity

Root cause analysis

CAPA

Change control

Audit readiness

Formação

Engineering or Science degree

Ferramentas

SCADA

Historians

LIMS

MES

Descrição da vaga

CareerWise Recruitment is seeking a Utility Technician for a leading pharmaceutical client in Waterford on a 23-month contract. The role covers regulatory compliance, quality oversight, data integrity, and engineering performance for clean utilities systems including WFI, Purified Water, Clean Steam, HVAC, and Compressed Air.

Responsibilities include oversight of IQ/OQ/PQ, audits, CQAs/CPPs, deviations, CAPA, and QMS tasks.