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Senior QA Specialist – Infrastructure and Logistics(m/w/x)
Ensuring GMP compliance for shared utility and logistics systems at a global pharmaceutical manufacturer. Academic degree and pharmaceutical QA experience required. Relocation assistance provided.
Requirements
- Academic degree in Pharmaceutical Sciences, Biochemistry, Engineering, Chemistry, or related field
- Work experience in Quality Assurance, Production/Supply Chain/Engineering, or Quality Control in pharmaceutical industries and cGMP-controlled environments
- Knowledge of Swiss, EU, and US GMP regulations for audits/inspections and compliance systems
- Strong verbal and written communication skills in English (German advantageous)
- Ability to communicate quality and compliance requirements to varying organizational levels
- Strong collaborative mindset and ability to build relationships quickly
- Strong organizational skills and ability to balance multiple priorities
- Problem-solving ability, understanding details and strategic picture, providing practical solutions
Tasks
- Implement and manage cross-functional support for facilities
- Assure Quality Assurance of sites and facilities
- Ensure shared utility systems meet standards
- Ensure logistics areas meet standards
- Provide QA support for GMP & Compliance
- Provide QA support for Cold-chain
- Provide QA support for supply chain
- Provide QA support for good warehousing practice
- Provide QA support for Clean utilities
- Provide QA oversight for shared utility systems
- Provide QA oversight for logistics areas
- Organize Deviation Review Boards
- Lead Deviation Review Boards
- Review Change Requests
- Assess Change Requests
- Review Corrective and Preventative Actions (CAPA)
- Assess Corrective and Preventative Actions (CAPA)
- Approve standard operation procedures for utilities
- Approve standard operation procedures for logistics
- Review GMP impact of utility alarms
- Review GMP impact of cold-chain alarms
- Review GMP impact of utility incidents
- Review GMP impact of cold-chain incidents
- Assist with operational readiness activities
- Assess risks in relevant areas
- Support internal audits
- Support external audits
- Support inspections
- Represent Quality at meetings
- Lead local implementation of global Quality policies
- Support local implementation of global Quality policies
- Lead local implementation of global Quality standards
- Support local implementation of global Quality standards
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degree
Languages
- English – Native
- German – Basic
Tools & Technologies
- cGMP
Benefits
Corporate Discounts
- Lifestyle benefits
- Leisure benefits
Family Support
- Family benefits
Other Benefits
- Relocation assistance
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Senior QA Specialist – Infrastructure and Logistics(m/w/x)
Ensuring GMP compliance for shared utility and logistics systems at a global pharmaceutical manufacturer. Academic degree and pharmaceutical QA experience required. Relocation assistance provided.
Requirements
- Academic degree in Pharmaceutical Sciences, Biochemistry, Engineering, Chemistry, or related field
- Work experience in Quality Assurance, Production/Supply Chain/Engineering, or Quality Control in pharmaceutical industries and cGMP-controlled environments
- Knowledge of Swiss, EU, and US GMP regulations for audits/inspections and compliance systems
- Strong verbal and written communication skills in English (German advantageous)
- Ability to communicate quality and compliance requirements to varying organizational levels
- Strong collaborative mindset and ability to build relationships quickly
- Strong organizational skills and ability to balance multiple priorities
- Problem-solving ability, understanding details and strategic picture, providing practical solutions
Tasks
- Implement and manage cross-functional support for facilities
- Assure Quality Assurance of sites and facilities
- Ensure shared utility systems meet standards
- Ensure logistics areas meet standards
- Provide QA support for GMP & Compliance
- Provide QA support for Cold-chain
- Provide QA support for supply chain
- Provide QA support for good warehousing practice
- Provide QA support for Clean utilities
- Provide QA oversight for shared utility systems
- Provide QA oversight for logistics areas
- Organize Deviation Review Boards
- Lead Deviation Review Boards
- Review Change Requests
- Assess Change Requests
- Review Corrective and Preventative Actions (CAPA)
- Assess Corrective and Preventative Actions (CAPA)
- Approve standard operation procedures for utilities
- Approve standard operation procedures for logistics
- Review GMP impact of utility alarms
- Review GMP impact of cold-chain alarms
- Review GMP impact of utility incidents
- Review GMP impact of cold-chain incidents
- Assist with operational readiness activities
- Assess risks in relevant areas
- Support internal audits
- Support external audits
- Support inspections
- Represent Quality at meetings
- Lead local implementation of global Quality policies
- Support local implementation of global Quality policies
- Lead local implementation of global Quality standards
- Support local implementation of global Quality standards
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degree
Languages
- English – Native
- German – Basic
Tools & Technologies
- cGMP
Benefits
Corporate Discounts
- Lifestyle benefits
- Leisure benefits
Family Support
- Family benefits
Other Benefits
- Relocation assistance
About the Company
Lonza
Industry
Pharmaceuticals
Description
Lonza is a global leader in life sciences, committed to improving lives through innovative solutions and ethical practices.
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