Social network you want to login/join with:
Responsibilities
* Ensure new products transferred to the client are manufactured following applicable regulatory requirements and policies.
* Maintain the effectiveness of the integration of new products into the quality system.
* Support 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.
* Review and approve 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, and provide input on quality concerns.
* Coordinate site review of new product related material specification documents including but not limited to in process, BDS, Drug Product, raw material, and excipient specifications.
* Manage new product related exception documentation, including the generation of corrective and preventative action to prevent reoccurrence.
* Generate product transfer documentation to attest the completion of product transfer deliverables in advance of the applicable product transfer stage gate review.
* Interface with internal auditors and outside regulatory agencies/auditors as the subject matter expert for new products and technology transfers.
* Adhere to and support all EHS & E standards, procedures, and policies.
Requirements
* 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.
* 2 Years’ experience gained within an aseptic processing environment, ideally gained within a quality function.
#J-18808-Ljbffr