We are seeking a dedicated professional to support the successful introduction of new products into our quality system.
About this role
This is an exciting opportunity for a seasoned Quality Specialist with expertise in New Product Introduction (NPI) compliance to join our team.
Key Responsibilities:
* To ensure that new products transferred to site are manufactured following applicable regulatory requirements and policies, maintaining the effectiveness of their integration into the NPI quality system.
* To provide direction on quality concerns, ensuring appropriate mitigation to address potential risk, collaborating closely with local and external cross-functional teams.
* To coordinate review of material specification documents including but not limited to in process specifications, Drug Product, raw material and excipient specifications at site level.
Requirements
The ideal candidate will possess:
lit A third-level qualification in science, quality or relevant discipline.
lit Strong knowledge of regulatory requirements is required Regulatory background (min 5 years).
lit At least three years experience gained within a related field - preferably supporting product introductions.