Quality Assurance Systems Lead

Objectives / Purpose of the Job

• Provide quality support to all manufacturing processes.
• Partner with Operations, Maintenance and other support functions to resolve issues on shift, contain non-conforming product, and ensure appropriate disposition and documentation.
• Oversee product and process performance using appropriate shift metrics.
• Conduct auditing activities to determine compliance and identify improvement opportunities.
• Support continuous improvement and corrective actions.
• Complete additional requirements specified by the Quality Engineering Manager.

Key Activities / 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.
•  

Supervise Direct Reports

No 

Scope of Position

The QA Shift Lead supports the manufacturing process in dealing with quality-related issues while ensuring compliance with applicable quality standards and GMP requirements. 

Key Relationships

• Production colleagues
• Production managers
• Maintenance technicians
• Warehouse colleagues
• Process Excellence Department
• Training Department
• QA Department
• Engineering Department
• HR Department
• IT Department 

Qualifications / Training

• Working knowledge of Microsoft Office products; ECDL qualification 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, able to prioritise and proactive.
• High attention to detail.
• Database-management experience is an advantage.
• Experience in a medical-device or pharmaceutical environment.
• Knowledge of cGMP, documentation control and computer systems.