Senior NPI Compliance Specialist
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| Job Type | Fixed Term |
| Area | Sligo, Ireland |
| Sector | Quality |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | #2811 |
| Job Views | 466 |
- Description
- An exciting opportunity has arisen for a Senior NPI Compliance Specialist for our client, an established global research-based biopharmaceutical company on a 12-month FTC.
In your new role as Senior NPI Compliance Specialist you will be responsible for ensuring new products transferred are manufactured in accordance with applicable regulatory requirements and procedures and policies. To ensure effective and compliant transfer of New Products to the site.
Why you should apply:
· There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally.
What you will be doing:
· Responsible for maintaining the effectiveness of the integration of new products into the NPI quality system.
· Ensuring that new products manufactured meet requirements of applicable regulatory requirements and procedures and policies.
· 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, management of 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, 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.
· 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.
Any other duties as assigned
What you need to apply:
· Third level qualification in a science, quality or relevant discipline required.
· Minimum of three years’ experience in a quality role supporting new product introductions.
· Strong knowledge of regulatory requirements is required.
High level of attention tntal concentration, to ensure
