SUMMARY
Join a pharmaceutical company with a portfolio of nearly 3,500 products, improving the lives of over 200 million patients across the globe. We believe quality medicines should be accessible to everyone, regardless of circumstance, and you can help us make that possible. As an aseptic professional at an aseptic, sterile vial fill & finish manufacturing facility, you'll be responsible for the quality review and approval of protocols, reports, and change controls regarding aseptic processes and media fill, as well as training and qualification for clean room. In addition, you'll support Quality Assurance activities such as authoring deviation investigations and change controls.
KEY DUTIES
- QA oversight of process/product validation, production and packaging-related investigations and change controls in support of both existing products and new product launches
- Resolution of complex work process issues through project management/execution, problem solving, risk analyses (FMEAs), and design/implementation process improvement solutions
- Development of plans and complex strategies for implementation of robust and efficient CAPA
- Execution and interpretation of key metrics using data and/or statistical analysis in support of Annual Product Review and Quality Metrics
- Support of quality risk assessment as well as effectiveness checks (as part of Change Control and CAPA processes)
- Demonstrates effective leadership and teamwork to junior and senior level Quality personnel
- Complies with all company policies and procedures, including safety rules and regulations, current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements applicable to aseptic/sterile manufacturing and packaging operations
QUALIFICATIONS & EXPERIENCE
- Bachelor's degree in Science or related field from an accredited college or university; minimum of 4 years of quality engineering or related QA experience in a cGMP manufacturing environment with at least 8 years in an aseptic/sterile environment
- Experience in Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements applicable to aseptic/sterile manufacturing and packaging environment
- Experience in Validation and Qualification - process, product, equipment, and EM
- Experience of Root Cause Analysis (5 Whys, 6M's, Is/Is Not, FMEA, etc.) in support of writing, reviewing, and approving investigations to determine root cause and adequate corrective/preventive actions to prevent recurrence
- Experience in auditing techniques in a cGMP aseptic/sterile facility
- Mastery of technical writing for investigations, protocols, and reports (English)
- Knowledge in applied statistics and trend analysis such as SPC, Capability Analysis, and regression analysis
- Knowledge of Lean/5s application
- Need experience in TrackWise and electronic maintenance programs
- Plus is experience with EAMS maintenance program and Oracle ERP system