Foundation in quality assurance roles focused in Quality Management Systems and GMP documentation (must have)
Support development of new equipment/technology introduction projects preferably within Packaging Area (must have)
Be knowledgeable about compliance and regulatory aspects for equipment validation operation and maintenance (must have)
Be knowledgeable about compliance and regulatory aspects of Devices /Combination products industry (preferable)
Support Readiness of manufacturing operations documents/systems to support new product/process/devices introduction including but not limited to SOPs Equipment Commissioning & Qualification (protocols testing reports etc. documents and provide deliveries in a timely manner (must have)
Effectively collaborate with key customers and support groups (e.g. Manufacturing staff Process Owners Quality Process Development System Owners/Equipment Maintenance etc..
Teamoriented with a focus on achieving team goals (must have)
Strong change management and project management skills (must have)
Expertise in MS Office (Word Excel PowerPoint MS Teams) (must have)
Expertise in computer applications such as Veeva CMMS (Maximo) Trackwise etc (preferrable)