Quality 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

Our client, a pharmaceutical company located in South Tipperary, is seeking a Quality Specialist. The successful candidate will support GMP Quality Assurance activities, including audits, documentation review, quality-system processes and continuous improvement.

Responsibilities:

• Complete audits of data, information, procedures, facilities, equipment and systems, including computer systems, to ensure compliance with SOPs, GMP and applicable regulations.
• Review and approve production and analytical documentation supporting the release of drug substance, drug product and packaged finished goods, ensuring conformance with SOPs, GMP and regulatory requirements, including support for QP certification.
• Communicate and collaborate with functional areas to develop effective working relationships and resolve comments or issues arising during audits and reviews.
• Support product recalls and stock recoveries, as required.
• Identify compliance gaps and recommend opportunities for continuous improvement.
• Create and maintain assigned SOPs.
• Perform and review complaint and deviation investigations, change controls and CAPAs.
• Support the induction process for new starters, where required.
• Follow established procedures and consult with the manager or supervisor regarding exceptions.
• Compile data for reports and presentations, interpreting information and drawing conclusions where required.
• Complete assignments to the required standards of compliance, efficiency, innovation, accuracy and safety, in accordance with regulatory requirements.
• Maintain current knowledge of cGMP requirements described in applicable worldwide regulations.
• Undertake additional quality activities as assigned by the manager or supervisor.

Qualifications & Experience:

• Degree in an Engineering or Science discipline.
• 3+ years’ experience in a broad quality-related role within the pharmaceutical, biopharmaceutical or wider life sciences industry.
• Broad experience across quality assurance activities, including documentation review, deviations, CAPAs, change controls, complaints and audit support.
• Good working knowledge of GMP requirements, quality systems and applicable pharmaceutical regulations.