Lilly's Drug Product External Manufacturing – US (DPEM) Quality Assurance needs to assure patients worldwide of safe and efficacious drug products through effective quality oversight of North American contract manufacturers and alliance partners.
Requirements
- 3+ years of experience in regulated manufacturing industry and/or quality experience; direct parenteral, device assembly, or final packaging experience preferred
- Experience with Pharma industry electronic systems (SAP, Trackwise, QualityDocs (Veeva))
- Previous experience with batch disposition for drug product manufacturing and packaging processes
- Technical understanding of cGMPs and Global Quality Standards/Quality Systems
- Knowledge of Pharmaceutical Manufacturing Operations
Responsibilities
- Complete batch record and media fill reviews, reporting any issues
- Determine final disposition of batches by reviewing all required documentation, including but not limited to, change controls and deviations
- Originate and investigate deviations associated with batch records/release processes
- Participate in the creation and revision of standard operating procedures, Master Batch Records and Master Packaging Orders
- Create Certificates of Analysis or other similar documentation for internal and external customers
- Review and approve documentation that supports manufacturing (e.g., deviations, changes, procedures, protocols), as applicable.
- Maintain material management (e.g. check all API restrictions in SAP and apply those restrictions as required)
Other
- Proven ability to work independently or as part of a team to problem solve
- Strong written and verbal communication skills
- Teamwork and interpersonal skills exhibited across functional areas
- Ability to organize, prioritize, multi-task, and influence diverse groups
- Strong decision making and problem-solving skills
