US: Corporate QA Project Manager
To see other opportunities,
please visit http://sqa.fyicenter.com
Date: 03-Dec-2014
Corporate QA Project Manager
Assist plants in conducting and documenting investigations as required, through remote and/or onsite support as assigned
Perform FDA Establishment Registrations (Drug, GDUFA, Device, Food, Tissue, Tobacco)
Read and interpret FDA regulations regarding establishment registrations and listings
Coordinate projects as needed that may arise from regulatory changes
Perform registrations for local US based licenses and permits
Coordinate and lead global QA and QA/Operations webinars monthly
Implement best practices, conduct training and mentor others in CAPA, Risk Management / FMEA, and other quality processes as assigned
Develop and implement process improvements and train the cross-functional teams / global organization on use
Create and revise procedural documents (WI, SOP, Job Aid) using an electronic change control system
Identify and manage continuous improvement projects with the objective of achieving quality / reliability goals, process efficiencies and cost improvements
Collect and compile QA metrics for the Corporate Management Review process, continuous improvement initiatives and other periodic quality assessments
May independently perform or contribute to global Corporate and Site level Internal Audits
Regular attendance is mandatory
EDUCATION, EXPERIENCE & SKILL REQUIRED:
Bachelor's Degree in a technical discipline
Seven plus (7+) years of experience in the pharmaceutical or medical device industry in a quality assurance role
Project Management experience is required
Risk Management / FMEA expertise is required
Proven track record for identifying and implementing continuous improvements
Excellent verbal and written communication skills
Proven success working hands-on with multifunctional, global teams
Demonstrated data analysis, problem solving and CAPA documentation skills
To apply for this position, please visit
this Website.
Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com
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