$350,000 Per Year
$850,000 Per Year
Develops and manages pharmaceutical GMP documentation systems. Prepares and reviews standard operating procedures, work instructions, and forms. Manages document change control system and version control processes. Ensures all GMP documents comply with regulatory and quality management standards. Maintains document management system (DMS) and ensures document accessibility. Conducts SOP training coordination and tracks training compliance records. Reviews batch manufacturing records and laboratory records for completeness. Manages master batch record preparation, review, and approval processes. Supports regulatory inspections with GMP documentation retrieval and review. Performs document gap analysis and implements documentation improvement programs. Manages controlled document distribution and retrieval of obsolete documents. Prepares GMP documentation sections for regulatory dossier submissions. Stays current with GMP documentation requirements, GAMP guidance, and regulations.