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Fresenius Kabi USA

GMP Compliance Officer – Regulatory Audits & CAPA Lead

town of grand island, NY

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About this opportunity

Fresenius Kabi USA lists this GMP Compliance Officer – Regulatory Audits & CAPA Lead opportunity in town of grand island, New York. Review the employer’s description below for duties, qualifications and application requirements.

Job description

Fresenius Kabi USA seeks a Compliance Officer to lead the Quality Systems at the Production Unit from a FDA and global perspective. You will mentor teams to address cGMP gaps, guide regulatory audits, and oversee CAPA documentation and annual product reviews.

Responsibilities include managing deviation investigations, complaints, and regulatory correspondence while ensuring timely regulatory deliverables and global database maintenance.

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