Specialist, NPI Compliance
- Sligo
- Contract
- Full-time
- Taking responsibility for maintaining the effectiveness of the integration of new products into the AbbVie NPI quality system.
- Ensuring that new products manufactured at AbbVie Ireland NL B.V. meet requirements of applicable regulatory requirements and AbbVie procedures and policies.
- Be responsible for supporting new product transfers to the site from development through to commercialization, liaising closely with local and external cross functional teams to provide direction on quality concerns and ensure appropriate mitigation to address potential risk.
- Supporting vendor evaluation and approval, management of all technical agreements from initiation, review, approval, and storage.
- Supporting review and approval of NPI related Analytical Test Method Transfers and / or validation.
- Collaborating with CMC QA, R&D, S&T, and other functional groups to maintain roles and responsibilities, identify potential quality issues, obtain an understanding of the quality compliance and provide input on quality concerns.
- Coordination of site review of new product related material specification documents including but not limited to, intermediate specifications, API specifications, Drug Product specifications, raw material specifications, and excipient specifications.
- Supporting review and approval of new product related analytical Test Method Transfers and/or validation.
- Supporting the management of new product related exception documentation including the generation of corrective and preventative action to prevent reoccurrence.
- Generation of product transfer documentation to attest the completion of product transfer deliverables, in advance of the applicable product transfer stage gate review.
- Interfaces with internal auditors and outside regulatory agencies/auditors as the subject matter expert for new products and technology transfers.
- Adheres to and supports all EHS & E standards, procedures and policies.
- A third level qualification in a science or quality discipline
- Minimum 3 years' Experience in Pharmaceutical or Sterile Manufacturing environment
- Strong written and verbal communication skills
- Strong work ethic