Evaluate, review, and approve validation master plans, protocols, and reports, ensuring compliance with regulatory requirements and company policies
Job Summary
Evaluate, review, and approve validation master plans, protocols, and reports, ensuring compliance with regulatory requirements and company policies.
Contribute to project tasks and milestones, organizing work to meet deadlines and applying basic team effectiveness skills within the immediate Work Team.
Adhere to all company and Good Manufacturing Practices (cGMP) procedures, safety regulations, and participate in the development of validation programs to stay current with cGMPs and industry standards.
Matching Summary
Evaluate, review, and approve validation master plans, protocols, and reports, ensuring compliance with regulatory requirements and company policies.
Skills & Requirements
Must-have
validation master plans
validation process documents
cGMP procedures
statistical analysis of testing results
regulatory requirements and company policies
Nice-to-have
AI tools for problem solving
continuous learning and professional development
collaborate effectively with colleagues
Key Requirements
Bachelor's degree with any years of experience
Associate's degree with 4 years of relevant experience
High school diploma with 6 years of relevant experience
Excellent attention to detail
Solid understanding of FDA Regulations/Guidance and cGMP
Proficiency in Microsoft Office, particularly Excel