Product Introduction Specialist
23 hours ago
Located on the picturesque west coast of Ireland, a leading pharmaceutical company is seeking an experienced New Product Introduction Specialist to join their state-of-the-art facility. The successful candidate will be responsible for ensuring new products are manufactured in accordance with applicable regulatory requirements and policies.
The ideal candidate will have a strong understanding of quality management systems and experience in supporting new product introductions. A background in regulatory affairs or a related field would be advantageous. Excellent communication and collaboration skills are essential for success in this role.
Key Responsibilities:
- Ensure compliance with regulatory requirements and policies during new product introductions
- Maintain the effectiveness of the integration of new products into the quality system
- Liaise with cross-functional teams to provide direction on quality concerns and ensure mitigation to address potential risk
- Support vendor evaluation and approval, managing technical agreements from initiation to review and storage
- Review and approve NPI-related analytical test method transfers and/or validation
- Collaborate with QA, R&D, S&T, clients, and other functional groups to maintain roles and responsibilities, identify quality issues, and obtain an understanding of quality compliance
- Coordinate site reviews of new product-related material specification documents, including in-process, BDS, drug product, raw material, and excipient specifications
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
- Regulatory, quality, and new product introduction background
- Extensive experience gained within an aseptic processing environment, ideally within a quality function
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