Senior Technician Quality Control

Life Science Recruitment; Leinster; On-site; EUR 40,000 - 55,000; Full time

Job summary

Life Science Recruitment is partnering with an award-winning pharmaceutical organisation based in Carlow, Ireland, to recruit a Quality professional for cGMP and regulatory compliance. The role involves supporting vaccine and biologic product manufacturing, testing, release, and documentation in a highly regulated environment.

You will collaborate with Quality, QC, Manufacturing and other teams to resolve queries, drive continuous improvement, and maintain a safe laboratory setting while

Qualifications

• Degree in Science, Engineering or similar.
• 2-4 years’ experience in the Pharmaceutical/Biopharmaceuticals industry with quality function exposure.
• Lean Six Sigma Yellow Belt or suitable alternative.
• Knowledge of cGMP in Laboratory Quality Systems.
• Proficiency in Microsoft Office and relevant computer applications.

Responsibilities

• Ensure compliance with cGMP, GDP, data integrity (ALCOA) and regulatory requirements across Quality activities.
• Support manufacturing, testing and release of vaccine and biologic products in line with procedures and standards.
• Collaborate with Quality, QC, Manufacturing to resolve quality-related queries and maintain compliance.
• Identify and support continuous improvement and compliance initiatives to enhance operational efficiency.
• Support business-critical projects within the Quality Department.
• Perform laboratory testing, including analytical and microbiological testing, and material inspections.
• Maintain a safe, compliant and qualified laboratory environment with PPE and safety adherence.
• Execute, review and support deviations, CAPAs, complaints, material qualification, validation and Quality Risk Management.
• Review batch records, material documentation, SOPs, GMP data and other quality-related documentation.
• Support development, revision and implementation of SOPs, procedures and training materials.
• Participate in training activities and provide support to team members as required.
• Work shift patterns where required to support manufacturing and Quality operations.

Skills

cGMP knowledge

GxP data integrity

Regulatory awareness

Microsoft Office

Quality collaboration

Education

Science degree

Engineering degree

Tools

Microsoft Office

Job description

We’re currently recruiting for an exciting opportunity with an award-winning pharmaceutical organization based in Carlow. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Key Responsibilities:

• Ensure compliance with cGMP, GDP, data integrity (ALCOA) and regulatory requirements across all Quality activities.
• Support the manufacturing, testing and release of vaccine and biologic products in accordance with site procedures and regulatory standards.
• Collaborate with Quality, QC, Manufacturing and other departments to resolve quality-related queries and maintain compliance.
• Identify and support continuous improvement and compliance initiatives to enhance operational efficiency.
• Support business-critical projects within the Quality Department.
• Perform laboratory testing, including analytical and microbiological testing, and material inspections to ensure specification conformance.
• Maintain a safe, compliant and qualified laboratory environment, adhering to PPE and safety requirements.
• Execute, review and support deviations, CAPAs, complaints, material qualification, validation and Quality Risk Management activities.
• Review batch records, material documentation, SOPs, GMP data and other quality-related documentation.
• Support the development, revision and implementation of SOPs, operational procedures and training materials.
• Participate in training activities and provide support to team members as required.
• Work shift patterns where required to support manufacturing and Quality operations.

Education and Experience:

• Degree in Science, Engineering or similar
• 2-4 years’ experience in the Pharmaceutical, Biopharmaceuticals industry or a similar operating environment which includes experience in a Quality function.
• Lean Six Sigma Yellow Belt or suitable alternative
• Knowledge of cGMP in Laboratory Quality Systems.
• Proficiency in Microsoft Office and job-related computer applications required