Quality Assurance Specialist

Life Science Recruitment; Carlow; On-site; EUR 42,000 - 62,000; Full time

Job summary

Life Science Recruitment is pleased to present an exciting opportunity with an award-winning Pharmaceutical organization based in Carlow.

The role targets a Quality professional with 1-2 years in a pharmaceutical manufacturing QA setting, familiar with SAP, MES, Trackwise and cGMP/GDP requirements. The position offers a collaborative, fast-paced environment and growth within a multinational.

Qualifications

• Bachelor’s degree or higher in science.
• 1-2 years experience in a quality role at pharmaceutical manufacturing facility, preferably aseptic manufacturing.
• Experience in SAP, MES, Trackwise.
• Working knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
• Knowledge of cGMP and GDP essential; report, standards, policy writing skills required.

Responsibilities

• Work a 4 shift pattern role.
• Perform timely reviews of batch documentation/investigations/reports highlighting and assist in the resolution of concerns commensurate with the risk.
• Respond quickly to unplanned events, technical issues.
• Operational experience of quality systems in a dynamic manufacturing environment e.g. SAP, Trackwise, MES.
• Full understanding of relevant quality and compliance regulations and requirements.
• Conduct, report and display of Quality right first time, audit readiness metrics weekly to ensure continuous audit readiness and cGMP compliance
• Support the spot check/walk-through process of the production lines
• Involved in customer complaint investigation if required
• Work well cross functionally and be an active team member

Skills

Quality Assurance

Regulatory knowledge

Cross-functional collaboration

Education

Bachelor’s degree or higher in science

Tools

SAP

MES

Trackwise

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:

• Work a 4 shift pattern role
• Technical knowledge of sterile manufacturing processes
• Perform timely reviews of batch documentation / investigations / reports highlighting and assist in the resolution of concerns commensurate with the risk
• Respond quickly to unplanned events, technical issues
• Operational experience of quality systems in a dynamic manufacturing environment eg SAP, Trackwise, MES
• Full understanding of relevant quality and compliance regulations knowledge of requirements for cGMP, US and EU regulatory requirements
• Conduct, report and display of Quality right first time, audit readiness metrics weekly to ensure continuous audit readiness and cGMP compliance
• Support the spot check/walk-through process of the production lines
• Involved in customer complaint investigation if required
• Work well cross functionally and be an active team member

Education and Experience:

• Bachelor’s Degree or higher preferred in a Science discipline
• 1-2 years experience in a Quality Role at pharmaceutical manufacturing facility preferably aseptic manufacturing
• Experience in SAP, MES, Trackwise
• Working knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
• Knowledge of cGMP and GDP essential Report, standards, policy writing skills required