Job Title:
Quality Auditor – P2
Location:
Tipperary, Ireland
Contract Type:
Fixed Term Contract- Hybrid/ Day role
Role Description
The contractor will be a member of the Quality Assurance team, supporting GMP compliance and quality activities within a regulated pharmaceutical environment. The role involves reviewing documentation, conducting audits, and ensuring that processes and products meet defined quality standards and regulatory requirements.
Key Responsibilities
* Review and approve production, analytical, and packaging documentation to ensure compliance with SOPs, GMP, and regulatory requirements.
* Communicate and collaborate with cross-functional teams to resolve issues and facilitate compliance.
* Support product recalls, stock recoveries, and other quality-related actions as needed.
* Identify compliance gaps and recommend improvements for continuous quality enhancement.
* Create, update, and maintain Standard Operating Procedures (SOPs).
* Perform and review investigations, change controls, deviations, complaints, and CAPAs.
* Assist with induction or onboarding of new team members, if required.
* Compile and interpret data for reports and presentations.
* Conduct audits of procedures, data, facilities, equipment, and systems (including computerized systems) to ensure regulatory compliance.
* Stay up-to-date with current Good Manufacturing Practice (cGMP) and regulatory requirements.
* Perform any additional tasks assigned by the manager or supervisor.
Experience, Knowledge & Skills
* Degree in an Engineering or Science discipline
or
equivalent industrial experience in a regulated environment.
* Knowledge of GMP, quality systems, and regulatory requirements.
* Strong analytical and problem-solving skills.
* Excellent communication and interpersonal skills for effective cross-functional collaboration.
* Attention to detail and ability to maintain high-quality standards under strict regulatory requirements.
Qualifications & Education
* Bachelor's degree in Engineering, Science, or a related discipline
or
substantial relevant industrial experience.
* Prior experience in a pharmaceutical or regulated manufacturing environment is preferred.