Lead Quality Assurance Specialist
4 days ago
At our organization, we are seeking a skilled Quality Assurance Specialist to join our team. This individual will be responsible for ensuring the highest level of quality in our products and services.
- Responsibilities:
- Collection, compilation, analysis, and review of all data for APQR;
- Processing and oversight of changes through generation, justification, impact assessment, modification, review, approval, and implementation workflow;
- Review and approval of all documentation associated with process validation, cleaning validation, and GMP equipment documents;
- Tracking, trending, and reporting of Quality Metrics for site, regional, and global review;
- Review and approval of all documentation associated with the establishment and configuration of a GMP computerized system;
- Management, tracking, and performance of GMP-type training supporting plant performance and Quality Departmental training and hands-on qualification;
- Review and approval of the Validation Master Plan and all documentation associated with the validation or qualification of a process, system, equipment, facility, and utilities.
Bachelor's or Master's degree in chemistry is required, along with 4-10 years of experience in the field. A strong understanding of quality assurance principles and practices is essential.
We offer a dynamic work environment with opportunities for professional growth and development. Our commitment to equal employment opportunity ensures that all candidates are treated fairly and without bias.
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