QA Validation Lead

at  Lonza

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
The Lead QA Validation Engineer is responsible for ensuring the timely development, review and approval of all validation programs and lifecycle documentation, (i.e. SOPs, Change Controls, CAPAs, Deviations), ensuring compliance with Corporate procedures, SOPs, cGMP, standards and implementing industry best practices.

KEY ACCOUNTABILITIES:

• Responsible for the Quality review and approval of validation documents to support validation requirements (Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), & Process Performance Qualification (PPQ). validation master plans, risk assessments, and periodic reviews, etc.).
• Participate with plant & external engineering resources on new installations & systems to ensure that factory, site, & commissioning documentation is in accordance with current Good Manufacturing Practices (“cGMP”) & supports validation.
• Support all aspects of the Validation Life Cycle from design through operation and improvements, and the revalidation program.
• Represent QA validation in multi-disciplinary teams focused on production facility build and laboratory move activities (working with commissioning, validation, and computerized system validation)
• Create, review, and approve Validation SOPs, Change Control and Corrective Action Preventive Action (CAPA) and additional documentation and quality systems such as SOPs, forms, reports, deviation, etc. as needed.
• Works directly with operating entities, with multiple functions, internal and external, to provide Quality validation support to assure requirements meet project expectation and meet local procedures and regulations.
• Interface with Manufacturing, Packaging, Engineering, MSAT, PD, and QA/QC departments to resolve process issues and implement changes.
• Identify, analyze, and manage risk through product life cycle with use of risk management tools.
• Assist investigation and reviews deviation investigations related to manufacturing process equipment, utilities, automation, computer systems, validation, and laboratory instruments.
• Participate in continuous quality system improvements and supports implementing improvements in the GMP Validation and Change Control Programs.
• Participate in internal, client and/or regulatory audits.
• Work with the site management in all areas to maintain a cGMP compliant facility
• Establish, maintain, trend and report Quality KPI and metrics
• Participate in Management Review, Quality Review Board Deviation Review Board and Change Review Board as required.

Key Requirements

• Bachelors Degree in a Science related Field
• Experience working in a Pharma cGMP environments

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 ethical
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 a disability, protected veteran status, or any other characteristic protected by law

Please refer the Job description for details