Quality, Science, Pharmaceutical & Food

• Support of vendor evaluation and approval, managing technical agreements
• Support of review and approval of NPI related analytical test method transfers
• Support of review and approval of NPI product transfers Must have previous experience working in NPI and understanding of the principles of start-up (product and/or process), aseptics, quality (QS and/or Quality Ops), analytical skills.

• To ensure new products transferred to site are manufactured following applicable regulatory requirements and policies.
• Responsible for maintaining the effectiveness of the integration of new products into the NPI quality system.
• NPI Compliance Specialist is 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.
• Support vendor evaluation and approval, managing all technical agreements from initiation, review, approval, and storage.
• Support review and approval of NPI related Analytical Test Method Transfers and/or validation.
• Collaborate with CMC QA, R&D, S&T, clients 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 in process, BDS , Drug Product , raw material and excipient specifications.
• Support review and approval of new product related analytical Test Method Transfers and/or validation.
• Support 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, quality or relevant discipline.
• A minimum of three years experience in a quality role supporting new product introductions.
• Strong knowledge of regulatory requirements is required
• Regulatory, quality and New product introduction background .
• Desirable: 2 Years’ experience gained within an aseptic processing environment, ideally gained within a quality function

PE Global