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Job Description:
Important qualities include the ability to work accurately and within agreed deadlines and in compliance with established working practices.
Representing as Subject Matter Expert in drug delivery device development and demonstrates knowledge and background in analytical method development, design verification, specification setting and stability testing for drug delivery devices.
The job requires close working with multidisciplinary teams comprising Design, Mechanical, Quality, Compliance Regulatory, Human Factors and formulation Engineers and Scientists, who are working on drug delivery device development / testing.
Major Duties:
• Works as part of a multidisciplinary team to determine what performance factors of the drug delivery device will require assessment and investigation.
• Support interactions with external vendors and internal partners within the following activities: design verification, shelf life studies, shipping studies, and manufacturing process qualification for drug delivery devices
• Assist preparation of regulatory submissions, internal and external audits.
• Apply statistical, scientific and engineering expertise and research experience to solve problems creatively and independently and support decision making.
• Apply method development and method validation principles to the qualification and use of bespoke test equipment.
• Uses analytical and statistical tools to analyse the data in order to quantify the functional performance characteristics of the drug delivery device, the controlling parameters for its consistent performance, etc.
• Able to define appropriate approaches to quantify design parameters, including design of experiments and statistical interpretation of data.
• Performs other duties as assigned in support of business goals e.g. hands-on testing