Growing company in the pharmaceutical capital equipment field can offer you an opportunity to build, develop and lead a global team in quality and safety . If you are a strategic professional seeking to apply your Leadership and Management skills than this opportunity will appeal to you.
- Support and maintain the Quality program, practices, procedures and guidelines, including best industry practices such a Good Documentation Practices (GDP).
- Coordinate CAPA activities and lead Quality Review Board (QRB)
- Coordinate and perform internal, process and mock customer audits
- Coordinate and perform vendor qualification or re-qualification audits
- Coordinate 3rd party audits of specified site as directed (ASME, National Board, etc.)
- Coordinate and support Customer audits of the site, as directed.
- Drive efficiency and productivity within the team.
- Coordinate Quality System Change Management system, including Documentation, Database and Material changes
- Coordinate calibration activities
- Bachelor’s Degree, in an Engineering discipline or related Science field (ex. Chemistry, Metallurgy)
- 5+ years post graduate work in a Quality or Validation fields
- 5+ years of management or leadership experience.
- Experience developing, maintaining, and presenting quality standards and training.
- Excellent interpersonal skills, ability to communicate and manage well at all levels of the organization.
- Knowledge of raw materials, production processes, quality control, and cost
- ASQ CQE, ASQ CQM and Six Sigma
Keywords: FDA, cGMP, ISO, ASQ, CQE, Six Sigma, CAPA, IQ/OQ
How To Apply:
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