Quality Systems Specialist

The Quality Systems Specialist role will develop and implement site Quality Systems to support the manufacture and release of Combination products, including SOPs, document control, change control, investigations, CAPA, internal auditing, Vendor qualification & management, material and batch disposition, complaints and annual product review.

Requirements

• Educated to degree level with proven industry experience
• Working knowledge of EU & US regulatory requirements
• Experience in designing and implementing quality systems and/or a start-up an advantage
• Experience in or knowledge of inhalation dosage forms an advantage
• High proficiency in Microsoft Word/Excel/PowerPoint/MS Project etc
• Proficiency in electronic systems/databases such as documentation, Trackwise, SAP etc
• Good team working and strong communication skills across functions and organization
• Ability to work flexibly in a changing environment
• Good attention to detail and priority management essential
• Flexibility to learn new skills and take on new tasks and responsibilities
• Ability to work under pressure to demanding schedules is important, as is the ability to work on one’s own initiative

Benefits

• Competitive salaries
• Benefits
• Inclusive environment