Description:
PE Global is currently recruiting for an NPI Compliance Specialist on behalf of a leading pharmaceutical company. This is an initial 12-month contract role where the specialist will be responsible for ensuring new products are transferred and manufactured following applicable regulatory requirements and policies.
Key Responsibilities:
* Maintain the effectiveness of new product integration into the quality system.
* Support new product transfers from development through to commercialization, collaborating with cross-functional teams to address quality concerns and mitigate potential risk.
* Evaluate and approve vendors, managing technical agreements and reviewing 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 compliance.
* Coordinate site reviews of material specification documents and support review and approval of analytical test method transfers.
* Manage exception documentation and generate corrective actions to prevent reoccurrence.
* Interface with internal auditors and outside regulatory agencies as the subject matter expert for new products and technology transfers.
Requirements:
* A third-level qualification in science, quality, or a relevant discipline.
* A minimum of three years' experience in a quality role supporting new product introductions.
* Strong knowledge of regulatory requirements is essential.
* Regulatory, quality, and new product introduction background is preferred.