Validation Lead

ABOUT THE ROLE

Reporting to the Quality Manager, the Validation Lead will be responsible for planning, scheduling, creating, and conducting any validation requirements in line with validation master plans. This role can be based in Cardiff, Coleraine or Comber.

KEY ACTIVITIES

• Author all validation protocols and report documentation for performance testing of new or modified equipment, processes or systems and to support ongoing improvements.
• Own the validation master plan, keeping up to date in real time, and scheduling activities in line with equipment, personnel and other stakeholder availability.
• Analyse data from validation activities to ensure processes are meeting required criteria
• Provide input to the QA monthly report, by providing line management with regular status updates and KPI reports on validation progress
• Line management responsibilities for a small team that support validation activity
• As a member of the QA team support the development and implementation of processes to imbed a strong QA culture.

Quality System

• Maintain files in accordance with relevant QMS procedures and make them available for review during Quality Audits.
• Support where required investigations into manufacturing issues or customer complaints

Health & Safety

• Following all Health & Safety guidelines within the Department and notifying the Company of any incident, accident or near miss.
• Wearing Personal Protective Equipment as required for the task being carried out

Other

• To adhere to the company’s Equal Opportunities policy and Dignity at work policy in all activities and to actively promote equality of opportunity wherever possible
• To be responsible for your own health and safety and that of your colleagues, in accordance with the company’s’ Health and Safety policy
• To adhere to the company’s Quality policy and Environmental policy
• To undertake other duties as may be reasonably required

KEY SKILLS

Essential

• Previous experience of validation activities in a Regulated Industry – ideally Medical Device Manufacturing, with knowledge of ISO 13485.
• Strong command of written English
• Excellent verbal communication skills
• Excellent organisational and planning skills
• Competent in the use of Microsoft office packages

Desirable

• Experience using statistical analysis packages
• Full driving license
• Coaching and mentoring skills
• Supervisory experience

KEY WORKING RELATIONSHIPS

Internal

• Quality Management
• Manufacturing
• Regulatory Affairs
• Supply Chain
• Procurement

External

• Notified Bodies and Competent Authorities
• Suppliers
• Contractors
• 3^rd party Clients

ADDITIONAL INFORMATION

• Occasional business travel when required
• Role can be based in Coleraine, Comber or Cardiff.

COMPETENCIES

Analytical – Enjoys analysing qualitative data but also considers quantitative and seeks to identify and explore they key elements in information before making commitments.  Tends to like to use facts and figures when planning and reporting and is concerned about accuracy and detail

Quality Orientation – Is precise, pays attention to details, checks things and ties up ‘loose ends’.  Has a strong conscience about getting things right and seeks to ensure that decisions and solutions do not involve undue risk, adheres to policy and standards.

Oral Communication – Talks readily and confidently to people, expressing themselves with obvious ease.  Speak out and makes themselves heard, often playing a leading and influential role in debate and discussion.

Interpersonal / Influencing – Deals with other in a convincing way that leads to gaining agreement without relying on hierarchy and shows sensitivity to working relationships.  Doesn’t give up easily in the face of opinions that differ from their own.  Influences others to reach conclusions and gain agreements.

Technical expert –full breadth of technical knowledge and can operate as a technical advisor, influencing others to achieve goals without relying on hierarchy. Keeps up to date on changes within their field and implements plans to ensure organisation is in a state of readiness.  Participates in industry and professional associations