Lonza
Key responsibilities
Manages and oversees the change control, deviation, CAPA and effectiveness check systems. Supports and trains site subject matter experts (SMEs) in how to execute change control, deviation, CAPA and effectiveness checks. Manages a team of individuals responsible for coordinating the site’s change control, deviation, CAPA and effectiveness check programs. Acts as a SME in how to execute compliant change control, deviation, CAPA and effectiveness checks. Supports the coordination and execution of complex change controls requiring sitewide implementation. Provide QMS leadership during eQMS development/improvement programs and/or projects involving department, cross-functional, and global teams. Functions as a TrackWise SME related to the change control, deviation, CAPA and effectiveness check modules. Supports and trains QMS Team hosts of change controls review board, deviation review board and CAPA review board. Acts as SME related to the change control, deviation, CAPA and effectiveness check systems in customer and Health authority inspections. Provides KPIs for change control, deviation, CAPA and effectiveness check systems. Key requirements
Bachelor's in Life Sciences, Engineering, Quality Management or related science discipline. 5+ years in a cGMP environment and related QA field. Experience with Health Authority Regulations (US FDA, EMA, MHRA, etc.). Experience in commercial pharmaceutical manufacturing environment. Experience in aseptic manufacturing environment. Certified Quality Auditor desired. Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.
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Manages and oversees the change control, deviation, CAPA and effectiveness check systems. Supports and trains site subject matter experts (SMEs) in how to execute change control, deviation, CAPA and effectiveness checks. Manages a team of individuals responsible for coordinating the site’s change control, deviation, CAPA and effectiveness check programs. Acts as a SME in how to execute compliant change control, deviation, CAPA and effectiveness checks. Supports the coordination and execution of complex change controls requiring sitewide implementation. Provide QMS leadership during eQMS development/improvement programs and/or projects involving department, cross-functional, and global teams. Functions as a TrackWise SME related to the change control, deviation, CAPA and effectiveness check modules. Supports and trains QMS Team hosts of change controls review board, deviation review board and CAPA review board. Acts as SME related to the change control, deviation, CAPA and effectiveness check systems in customer and Health authority inspections. Provides KPIs for change control, deviation, CAPA and effectiveness check systems. Key requirements
Bachelor's in Life Sciences, Engineering, Quality Management or related science discipline. 5+ years in a cGMP environment and related QA field. Experience with Health Authority Regulations (US FDA, EMA, MHRA, etc.). Experience in commercial pharmaceutical manufacturing environment. Experience in aseptic manufacturing environment. Certified Quality Auditor desired. Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.
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