Quality Auditor II

eTeam; Clonmel; Hybrid; EUR 37,000 - 63,000; Full time

Job summary

eTeam in Ireland is seeking a QA Auditor to ensure data, procedures, facilities and systems comply with SOPs, GMPs and regulations. You will review documentation for drug substance, drug product and finished goods, supporting QP certification where needed.

The role requires collaboration across functions to resolve comments and maintain SOPs and CAPAs, with cGMP awareness and a focus on safety and accuracy. Hybrid work (1–2 days from home) in Ballydine Kilsheelan, Clonmel, Co.

Qualifications

• A degree in an Engineering or Science discipline or significant industrial experience.

Responsibilities

• Completes audits of data, information, procedures, facilities, equipment and systems (inc computer systems) to ensure compliance to SOPs, GMPs and applicable regulations.
• Review and approve production and analytical documentation accompanying the release of drug substance, drug product and packaged finished goods to ensure conformance to appropriate SOPs, GMP and regulatory requirements, including supporting QP certification.
• Actively communicate and collaborate with functional areas to develop a strong working relationship and understanding of roles and responsibilities. Utilise this network to help resolve comments and issues that arise during audit and review.
• Support product recalls and stock recoveries as appropriate.
• Identify compliance gaps and make recommendations for continuous improvement
• Creates and maintains assigned SOPs.
• Perform and review complaints and deviation investigations, change controls and CAPA’s.
• May assist in the induction process for new starters.
• Generally follows standard procedures and consults with manager/supervisor on exceptions.
• Compiles data for reports and presentations - May interpret data and draw conclusions.
• Carries out all assignments to the standards of compliance, efficiency, innovation, accuracy and safety in accordance with Company and regulatory requirements.
• Keep abreast of cGMP requirements as described in applicable worldwide regulations.

Education

Engineering or Science degree

Job description

Work location: Ballydine Kilsheelan, Clonmel, Co. Tipperary

Pay rate: €26.78/h - €45.46/h - Standard working hours, no shifts

Work model: Hybrid (1-2 days from home)

Contract duration: 11 months with a possibility of extension

Client: A leading global healthcare company focused on the research, development, and production of innovative medicines and vaccines.

Responsibilities

• Completes audits of data, information, procedures, facilities, equipment and systems (inc computer systems) to ensure compliance to SOPs, GMPs and applicable regulations.
• Review and approve production and analytical documentation accompanying the release of drug substance, drug product and packaged finished goods to ensure conformance to appropriate SOPs, GMP and regulatory requirements, including supporting QP certification.
• Actively communicate and collaborate with functional areas to develop a strong working relationship and understanding of roles and responsibilities. Utilise this network to help resolve comments and issues that arise during audit and review.
• Support product recalls and stock recoveries as appropriate.
• Identify compliance gaps and make recommendations for continuous improvement
• Creates and maintains assigned SOPs.
• Perform and review complaints and deviation investigations, change controls and CAPA’s.
• May assist in the induction process for new starters.
• Generally follows standard procedures and consults with manager/supervisor on exceptions.
• Compiles data for reports and presentations - May interpret data and draw conclusions.
• Carries out all assignments to the standards of compliance, efficiency, innovation, accuracy and safety in accordance with Company and regulatory requirements.
• Keep abreast of cGMP requirements as described in applicable worldwide regulations.

Additional activities may be assigned by the manager/supervisor

Expectations

• A degree in an Engineering or Science discipline or significant industrial experience.