QA Shift Lead – GMP, CAPA & Continuous Improvement

Bausch + Lomb; Dublin; On-site; EUR 52,000 - 75,000; Full time

Job summary

Bausch + Lomb in Ireland is seeking a QA Shift Lead to support manufacturing quality processes on the floor, ensuring compliance with GMP and QMS requirements. You will oversee product and process performance, contain non-conforming product, and drive investigations and CAPA activities.

As a QA Shift Lead, you will supervise quality-related decisions on a shift-by-shift basis, analyze data, and collaborate with Production, Maintenance and other departments to uphold product quality and

Qualifications

• Working knowledge of Microsoft Office; ECDL desirable.
• Familiarity with Documentum or similar documentation systems is desirable.
• Working knowledge of CAMS and CATSweb.
• Understanding of existing quality and manufacturing systems and procedures.
• Strong verbal and written communication skills.
• Excellent numerical skills.
• Decisive, self-motivated, capable of working on own initiative.
• High attention to detail.
• Experience in a medical-device or pharmaceutical environment.
• Knowledge of cGMP, documentation control and computer systems.

Responsibilities

• Coordinate containment of non-conforming product and material as required.
• Assist with quality-related product and material disposition decisions on the manufacturing floor.
• Make appropriate product-disposition and quality decisions on a shift-by-shift basis.
• Lead investigations into floor quality issues to determine root cause and corrective actions.
• Assist with initiation and processing of Non-Conformance Reports (NCRs).
• Perform data analysis and trending.
• Support complaint management and investigation when required.
• Independently review records as required.
• Support process and Quality System improvement.
• Initiate CAPA where relevant.
• Ensure process audits are completed as required.
• Escalate quality‑related issues to Quality Engineering as necessary.
• Complete other QA duties, including project support.
• Follow Standard Operating Procedures at all times.
• Maintain awareness of applicable standards and QMS requirements.
• Follow gowning procedures and entry rules for manufacturing and controlled areas.
• Follow Personal Hygiene Rules defined in the GMP Training Programme and notify supervision of health conditions that may affect product quality.
• Maintain a clean and tidy work area.

Skills

Microsoft Office

Documentum

CAMS

CATSweb

Quality systems

Communication skills

Attention to detail

GMP knowledge

Tools

Documentum

CAMS

CATSweb

Job description

Bausch + Lomb in Ireland is seeking a QA Shift Lead to support manufacturing quality processes on the floor, ensuring compliance with GMP and QMS requirements. You will oversee product and process performance, contain non-conforming product, and drive investigations and CAPA activities.

As a QA Shift Lead, you will supervise quality-related decisions on a shift-by-shift basis, analyze data, and collaborate with Production, Maintenance and other departments to uphold product quality and