GMP Quality & Compliance Specialist

Tandem Project Management Ltd.; Tipperary; On-site; EUR 55,000 - 75,000; Full time

Job summary

Tandem Project Management Ltd. is seeking a Quality Specialist for a pharmaceutical client in South Tipperary to support GMP QA activities, audits, and continuous improvement.

The role involves reviewing documentation, CAPA and deviation management, change controls, and support for product release, while ensuring regulatory compliance and cGMP knowledge. The ideal candidate will have a degree in a science or engineering discipline and at least 3 years in a quality role within pharma or life

Qualifications

• 3+ years of experience in a broad quality-related role within pharma/life sciences.
• Experience in documentation review, deviations, CAPAs, change controls, complaints, and audit support.
• Knowledge of GMP requirements and regulatory pharmaceutical standards.

Responsibilities

• Conduct audits of data, facilities, equipment, and systems to ensure GMP compliance.
• Review and approve production and analytical documentation for release of drug substances and products.
• Support recalls, stock recoveries, and quality investigations (complaints, deviations, CAPAs).
• Maintain SOPs and assist new starters; prepare reports and data presentations.
• Stay updated on cGMP regulations and assist continuous improvement initiatives.

Skills

Quality Assurance

GMP compliance

Audits

CAPA management

Documentation review

Education

Bachelor's degree in Engineering or Science

Job description

Tandem Project Management Ltd. is seeking a Quality Specialist for a pharmaceutical client in South Tipperary to support GMP QA activities, audits, and continuous improvement.

The role involves reviewing documentation, CAPA and deviation management, change controls, and support for product release, while ensuring regulatory compliance and cGMP knowledge. The ideal candidate will have a degree in a science or engineering discipline and at least 3 years in a quality role within pharma or life