Summary: Seeking a Quality Assurance Manager with a strong background in pharmaceuticals to oversee and ensure compliance with Quality Policies and Standards.

Key Responsibilities:

Supervise Operational Quality Assurance activities for compliance with Quality Policies and Standards.

Provide leadership to the Quality Assurance team.

Draft, review, and approve Deviations, Change Controls, and Manufacturing Instructions.

Oversee the release of in-process and finished products.

Lead investigations of deviations and CAPAs, including OOS for Release/Stability and OOTs.

Support QC testing and sample management programs.

Execute quality-related processes and projects.

Qualifications:

Bachelor's degree in a scientific discipline required.

Minimum six years of experience with FDA and cGMP requirements in the pharmaceutical industry.

Minimum six years of experience in QA/QC practices within a pharmaceutical environment.

Comprehensive understanding of manufacturing within a cGMP environment, including documentation and data integrity.

Preferred Skills:

Direct experience with CAPA (Corrective Action/Preventive Action) processes.

Experience handling Deviations within pharmaceutical manufacturing.