Skills, Knowledge, Experience & Qualifications

• Relevant qualification in Science, Laboratory Techniques, Quality, Medical Device Manufacturing or a related discipline, and/or relevant experience within a medical device, pharmaceutical or other regulated manufacturing environment.
• Working knowledge of GMP, good documentation practices and Quality Management System requirements, with an understanding of the importance of traceability, document control and accurate quality records.
• Demonstrated ability to accurately perform and document Quality Control inspection and processing activities and review manufacturing and GMP records against approved requirements.
• Strong attention to detail, analytical and problem-solving skills, with the ability to identify discrepancies, gather and evaluate information and contribute to quality investigations and root cause analysis.
• Strong organisational and document-management skills, with the ability to manage multiple Quality activities and maintain accurate controlled records.
• Sound communication and interpersonal skills, with the ability to communicate quality concerns constructively, participate in audits and work effectively across Quality, Manufacturing and other functions.
• Proficient computer skills and the ability to work effectively both independently and as part of a multidisciplinary team.
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