Computer Systems Quality Assurance Specialist
We are seeking an experienced Quality Assurance Specialist to join our global team. This role will be based in a state-of-the-art manufacturing facility and will play a critical part in maintaining the quality and regulatory compliance of our biopharmaceutical products.
The successful candidate will work closely with cross-functional teams to implement and uphold quality assurance standards, facilitate inspections and audits, and support continuous improvement initiatives. Key responsibilities include developing and maintaining quality assurance procedures, policies, and systems, conducting routine self-inspections and monitoring assessments, collaborating with automation, IT and production teams, investigating and addressing deviations, non-conformities, and CAPA (Corrective and Preventive Actions), and ensuring compliance with periodic review, change control, deviation, back up and archive, security, and other support processes for systems.
To succeed in this role, you will need a BSc, Hons BSc, MSc, or PhD in Science, Engineering, Quality, or related discipline, 3+ years of experience in quality assurance within a biotechnology, pharmaceutical, or medical device manufacturing environment, strong knowledge of cGMP, FDA, Data Integrity, Quality Risk Management and other biopharmaceutical regulatory requirements, excellent problem-solving and analytical skills, detail-oriented with a strong commitment to maintaining high-quality standards, effective communication and teamwork skills, and experience with quality management systems (e.g., TrackWise) and automation systems (e.g., DCS, DeltaV).
This is an exciting opportunity to work in a fast-paced industry and contribute to the development of high-quality products. If you are passionate about quality and want to make a real difference, we encourage you to apply for this position.