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NPI Compliance Specialist - Life Sciences - Ireland - 12-month contract
Located on the picturesque west coast of Ireland, our global pharmaceutical client is seeking an NPI Compliance Specialist to join their state-of-the-art pharmaceutical facility.
Situated in the historic province of Connacht, near the Atlantic Ocean, this location offers a blend of Irish culture and modern amenities in a seaside town known for its vibrant bars, restaurants, and water sports.
Responsibilities
* Ensure new products are manufactured following applicable regulatory requirements and policies.
* Maintain the effectiveness of the integration of new products into the NPI quality system.
* Support new product transfers from development to commercialization, liaising with cross-functional teams to address quality concerns and mitigate risks.
* Support vendor evaluation and approval, managing technical agreements from initiation through review, approval, and storage.
* Review and approve NPI-related Analytical Test Method Transfers and validations.
* Collaborate with CMC QA, R&D, S&T, clients, and other groups to identify quality issues and ensure compliance.
* Coordinate review of material specifications related to new products, including in-process, BDS, Drug Product, raw materials, and excipients.
* Manage exception documentation and generate corrective and preventative actions.
* Prepare product transfer documentation for stage gate reviews.
* Interface with auditors and regulatory agencies as a subject matter expert.
* Adhere to EHS & E standards, procedures, and policies.
Requirements
* A third-level qualification in science, quality, or a relevant discipline.
* Minimum of three years' experience supporting new product introductions in a quality role.
* Strong knowledge of regulatory requirements.
* Experience in an aseptic processing environment, preferably within a quality function.
* Excellent interpersonal and decision-making skills, with project leadership experience.
* High attention to detail and focus to ensure accuracy and compliance with quality procedures.
If you're interested in this role, apply today!
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