We are seeking an NPI Compliance Specialist to join our Global pharmaceutical client's team in Ireland. This role involves ensuring new products are manufactured in accordance with regulatory requirements and policies.
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Job Description
As an NPI Compliance Specialist, you will be responsible for maintaining the effectiveness of the integration of new products into the quality system, supporting new product transfers from development through to commercialization, and collaborating with cross-functional teams to identify potential quality issues and provide input on quality concerns.
Key Responsibilities:
* Ensure compliance with regulatory requirements and company policies.
* Maintain the effectiveness of the integration of new products into the quality system.
* Support new product transfers from development through to commercialization.
* Collaborate with CMC QA, R&D, S&T, clients, and other functional groups to maintain roles and responsibilities.
* Identify potential quality issues and provide input on quality concerns.
Requirements
To be successful in this role, you will need a third-level qualification in a science, quality, or relevant discipline, as well as a minimum of three years' experience in a quality role supporting new product introductions. Strong knowledge of regulatory requirements is also essential.
In addition, we are looking for candidates with regulatory, quality, and New Product Introduction background, as well as experience gained within an aseptic processing environment, ideally gained within a quality function.