Quality specialist npi at Gertek Project Management

Job Description:

Latest job information from Gertek Project Management for the position of Quality specialist npi. If the Quality specialist npi vacancy in Sligo matches your qualifications, please submit your latest application or CV directly through the updated Jobkos job portal.

Please note that applying for a job may not always be easy, as new candidates must meet certain qualifications and requirements set by the company. We hope the career opportunity at Gertek Project Management for the position of Quality specialist npi below matches your qualifications.

Ger TEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services. We partner with many of the world's largest life science & technology companies who entrust in us to deliver their most strategic and important projects with our technically strong personnel ensuring all important activities meet both current requirements and client's needs. We have multiple projects that we support, and we are looking to add to our team, we are interested in talking to you if you fit the criteria outlined below: We are seeking an NPI Compliance Specialist for our Sligo based client. Key Responsibilities: 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. 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. Desirable: 2 Years' experience gained within an aseptic processing environment #Gertek To start the process click the Continue to Application or Login/Register to apply button below.

Job Info:

• Company: Gertek Project Management
• Position: Quality specialist npi
• Work Location: Sligo
• Country: IE

How to Submit an Application:

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