Quality R&D Specialist - Drug Delivery Systems (11300)

We are looking for a Quality R&D Engineer with a focus on our Drug Delivery Systems.

The person will support the Product Development Team in their quest to get new products to market in the most efficient and effective way. Strengthen the Quality Management System in compliance with applicable standards & regulations. Ensure products released for the market have the proper well-controlled product and process design system that ensures that new products are introduced to our product portfolio and enter the market as soon as possible and with minimum risk. Deliver knowledge of the requirements of the Quality System Regulations and the expectations of both the regulatory authorities and our customers' needs in terms of documentary evidence of a product development process under complete control.

KEY ACCOUNTABILITIES Establish and maintain the Design and Development Procedures and Templates in compliance with the Quality System Regulations and pertinent ISO standards (ISO 15378, ISO 13485, ISO 14971, 21 CFR part 820, EU GMP's Annex 20 and ICH Q). Support the Product Development team in planning the stages of the product development process (Design Planning, Design inputs, Design outputs, Design review, Design verification, Design validation, Risk management, Change control, Post-market information). Support the Product Development team in the redaction of the technical documentation in compliance with the Design and Development Procedures System procedures. Extend the change control procedures to the design and development process and the complete product lifecycle, in compliance with ISO 13485, 15378 and 21 CFR Part 820.30.


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