Lonza
Senior QA Expert - Equipment Qualification & Validation(m/w/x)
Full-timeOn-siteSenior
Stein (AR)
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LOLonza
QA Expert - Equipment Qualification & Validation and Data Integrity(m/w/x)
Stein (AR)
Full-timeOn-siteExperienced
Nejo AI Summary
Leading equipment and infrastructure qualification in GMP settings, co-leading site data integrity programs. Solid experience with aseptic fill&finish lines in GMP environment required. Relocation assistance provided.
Requirements
- Solid experience with aseptic fill&finish lines in a GMP environment
- Solid experience with qualification and validation of production equipment
- Experience with health authorities audit and customer inspections
- Degree in life science or equivalent experience
- Value teamwork and positive work culture
- Experience or interest in data integrity topics
- Fluency in English; German language skills advantageous
Tasks
- Lead qualification and validation activities for equipment and infrastructure
- Support data integrity activities, including attending deviation review boards
- Prepare site data integrity assessments and reports
- Host site data integrity meetings
- Co-lead the site data integrity program
- Act as a contact person for GMP-related issues and deviations
- Ensure adherence to qualification strategies during CAPEX and OPEX projects
- Supervise GMP status and trending of equipment
- Manage (re-)qualification and (re-)validation of production equipment
- Ensure compliance with change control management and CAPA handling
- Serve as a subject matter expert during audits and inspections
- Oversee life cycle management of qualification documents, including SOPs and protocols
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degree
Languages
- English – Native
- German – Basic
Benefits
Corporate Discounts
- Lifestyle benefits
- Leisure benefits
Family Support
- Family benefits
Other Benefits
- Relocation assistance
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Lonza and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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LOLonza
QA Expert - Equipment Qualification & Validation and Data Integrity(m/w/x)
Stein (AR)
Full-timeOn-siteExperienced
Nejo AI Summary
Leading equipment and infrastructure qualification in GMP settings, co-leading site data integrity programs. Solid experience with aseptic fill&finish lines in GMP environment required. Relocation assistance provided.
Requirements
- Solid experience with aseptic fill&finish lines in a GMP environment
- Solid experience with qualification and validation of production equipment
- Experience with health authorities audit and customer inspections
- Degree in life science or equivalent experience
- Value teamwork and positive work culture
- Experience or interest in data integrity topics
- Fluency in English; German language skills advantageous
Tasks
- Lead qualification and validation activities for equipment and infrastructure
- Support data integrity activities, including attending deviation review boards
- Prepare site data integrity assessments and reports
- Host site data integrity meetings
- Co-lead the site data integrity program
- Act as a contact person for GMP-related issues and deviations
- Ensure adherence to qualification strategies during CAPEX and OPEX projects
- Supervise GMP status and trending of equipment
- Manage (re-)qualification and (re-)validation of production equipment
- Ensure compliance with change control management and CAPA handling
- Serve as a subject matter expert during audits and inspections
- Oversee life cycle management of qualification documents, including SOPs and protocols
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degree
Languages
- English – Native
- German – Basic
Benefits
Corporate Discounts
- Lifestyle benefits
- Leisure benefits
Family Support
- Family benefits
Other Benefits
- Relocation assistance
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Lonza and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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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