Provides support that facilitates seamless execution of the overall objectives of the Quality Department. Supports the administration of Quality Assurance documentation programs, procedures, and controls ensuring that performance and quality of products conform to established Corden Pharma (CP) standards and Federal regulations.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Provides support for the QA Manager of Commercial Products in a professional and timely manner to include compiling and communication of KPI’s, composition of departmental correspondence, distribution of departmental reports, and other duties and special projects as needed.
- Management of Quality Systems including, but not limited, to deviations, change control, and Corrective Actions, Preventative Actions (CAPA)
- Review and approves master documentation for completeness and adherence to CPC templates and documentation standards.
- Review and approves executed pharmaceutical batch record production records for GMP compliance and consistency with internal policies and procedures to support product disposition of commercial intermediates and API.
- Subject matter expert and trainer in batch record review.
Works directly with internal and external customers to ensure adherence to quality standards.
- Maintains Quality Department regulatory document master files in compliance with retention schedules and other applicable corporate and regulatory requirements. Maintains all documentation located in the Quality Retention room, which includes Master Batch Records and change control documentation for production and development operations.
- Issues controlled documentation including batch records, laboratory notebooks, methods, specifications, and labeling by ensuring the copy is a replicate of the master production instructions for each intermediate and API (if applicable).
- Serves as the backup Administrator for the QA Documentation Specialist of the Quality Department records database (Tabfusion) and off-site records storage duties (Iron Mountain).
- Able to react to change productively and handle other essential tasks as assigned.