Experience managing client/vendor relationships
Required knowledge of manufacturing/packaging operations; including environmental monitoring, drug product manufacturing/packaging, product shipping, ancillary systems/utilities (i.e. HVAC, water, compressed gases), stability testing and release testing
Experience supporting cross-functional project teams
Ability to troubleshoot manufacturing/packaging process deviations and analytical OOS results as needed
Experience dealing with external supply world, contract manufacturing
Product knowledge of Non Sterile Products- tablets, capsules, ointments/creams, etc.
Experience in TrackWise based system or similar systems- customer complaints, deviations, etc.
Strong Communication Skills both oral and written- Savvy in electronic systems as well
Requires knowledge of Quality Systems, FDA GxP regulations and guidance for pharmaceutical manufacturing.
Requires excellent verbal/written communication, negotiation/influencing, leadership and risk assessment skills.
Ability to author quality agreements with contract development, manufacturing, and laboratory organizations.
Understands quality by design principles and how to define critical process parameters.
Can conduct FMEA to assess risk and identify risk mitigation actions
Complete Annual Product Quality Reports (APQR)
Review statistical analysis that measures process capability and trending performance.
Experience in negotiation/influencing and management of remote third party partners
Ability to work independently on problems and issues and determine acceptable solutions and approaches
Requires strong computer skills in MS Word, Excel, PowerPoint, Adobe Acrobat, Trackwise, SAP, and the ability to learn/execute data entry into various databases
Awareness of standard health, safety and environmental requirements in pharmaceutical manufacturing
Source: Job Diva – Job Listing