NPI Compliance Specialist Role
This 12-month contract opportunity is perfect for a regulatory professional seeking to work with a leading pharmaceutical client in the picturesque west coast of Ireland.
* Ensure new products are manufactured following applicable regulatory requirements and policies.
* Maintain the effectiveness of the integration of new products into the NPI quality system.
* Support new product transfers from development through to commercialization, collaborating with cross-functional teams to address potential risk.
* Manage vendor evaluation and approval, technical agreements, and analytical test method transfers.
* Collaborate with CMC QA, R&D, S&T, clients, and other functional groups to identify quality issues and provide input on concerns.
* Coordinate site reviews of new product related material specification documents, including in-process, BDS, Drug Product, raw material, and excipient specifications.
* Support the management of new product related exception documentation, including corrective and preventative action.
* Generate product transfer documentation to attest the completion of deliverables.
Requirements:
* A third-level qualification in a science, quality, or relevant discipline.
* A minimum of three years' experience in a quality role supporting new product introductions.
* Strong knowledge of regulatory requirements.
* Regulatory, quality, and new product introduction background.
* Experience gained within an aseptic processing environment, ideally in a quality function.
* Strong interpersonal and decision-making skills with experience leading projects.
* A high level of attention to detail and mental concentration.