Quality Engineer

Responsibilities

• Provide guidance and feedback on quality issues
• Lead customer complaint and quality investigations
• Work with relevant departments to ensure timely closure of actions
• Participate in supplier and regulatory audits
• Support manufacturing operations to ensure products are produced to specification and the validated state of the cleanroom is maintained
• Perform critical and constructive review of procedures, processes and products
• Ensure equipment, systems, cleanrooms and products are always following applicable requirements
• Support technical transfer of products
• Own and manage relevant sections the quality management system
• Support sterility assurance activities per relevant ISO standards and internal procedures
• Support bioburden and endotoxin programs
• Promote a Quality culture and encourage Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP)
• Lead internal audits and provide guidance on suitable actions
• Support other tasks as requested by the Quality Manager. The responsibilities of the role may change and develop with the needs of the organization

Qualifications

• Minimum 3 years experience in a related role.
• Third level qualification (degree in science, engineering or related discipline preferred)
• Experience working in a manufacturing environment, preferably pharmaceutical, bio-pharmaceutical or medical device industries.
• Very good knowledge of GMP (Good Manufacturing Practice) requirements in a regulated environment.
• Takes personal responsibility for their actions. Self-starter and able to work under minimum supervision.
• Must have good communication and interpersonal skills to work in multidisciplinary teams.
• Effective oral and written communication skills are essential to this role.

• Private Medical Insurance 
• Company pension 
• Serious Illness Income protection
• Life Insurance
• Company and personal performance related bonus plan/structure
• Continuous Professional Development supported through Training & Development