Mange QA/GMP data and document transfer from third party to a secure client document retention location.
Ensure a user-friendly document inventory structural design that facilitates document retrieval.
Create a document master file.
Audit documentation transfer to ensure complete transfer of all expected files.
Experience managing client/vendor relationships, ability to work with IT team.
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
Product knowledge of Sterile Sterile Products-
Experience in TrackWise based system or similar systems- customer complaints, deviations, etc.
Strong Communication Skills both oral and written- Savy 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.
Excellent organizational skills and attention to detail.
Can conduct FMEA to assess risk and identify risk mitigation actions
Complete Annual Product Quality Reports (APQR)
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
Source: Job Diva – Job Listing