NPI Compliance Specialist

3 days ago

Sligo, Sligo, Ireland Quanta part of QCS Staffing Full time
NPI Compliance Specialist - Life Sciences - Ireland - 12-month contract

Located on the picturesque west coast of Ireland, our Global pharmaceutical client is looking for a NPI Compliance Specialist to join their state of the art pharmaceutical facility.

Located in the historic province of Connacht neighbouring the pond that is the Atlantic Ocean, breeds a mix of Irish culture and modernisation in the popular seaside town rife with bars, restaurants and water sports.

Responsibilities 
To ensure new products ae manufactured following applicable regulatory requirements and policies. Responsible for maintaining the effectiveness of the integration of new products into the NPI quality system. 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. 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. Experience gained within an aseptic processing environment, ideally gained within a quality function. Strong knowledge of regulatory requirements is required. Strong interpersonal and decision-making mindset with experience leading projects. High level of attention to detail and mental concentration to ensure accuracy and total compliance with Quality procedures at all time. If you're interested in this role, apply today 

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