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.
Troubleshoot validation problems for equipment and performance processes, conducting statistical analysis of testing results to address process anomalies.
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
Nice-to-have
technical writing experience
pharmaceutical industry experience
AI tools for productivity
cross-functional collaboration
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
Proficiency in Microsoft Office, particularly Excel
Understanding of Food and Drug Administration Regulations/Guidance