My client is a fast growing pharma company looking for QA Manager.
QA lead for internal GMP Manufacturing and QC operations.
Review and approval of Master Documents (batch records, protocols, reports, etc.)
Point person and final approver of deviation and OOS investigations.
Executed documentation/record review and approval.
Oversee, approve equipment qualifications and process validations.
Experience with FDA inspection
Min Bachelors degree in Life Sciences or related field.
Min 3 years of Quality Assurance experience in a pharmaceutical or biotech company.
Experience in development, implementation of Quality Systems is preferred.
Experience with FDA submissions a plus
Strong knowledge of global regulatory and cGMP compliance standards.