Lonza
Functional Lead QA CSV(m/w/x)
Full-timeOn-siteSenior
Visp
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LOLonza
QA Manager CSV, Capital Projects(m/w/x)
Visp
Full-timeOn-siteExperienced
Nejo AI Summary
CSV QA management for Syncade and DeltaV recipe objects in pharmaceutical CAPEX projects. Broad knowledge of CSV, Data Integrity, and regulatory guidelines required. Agile career path, lifestyle and family benefits.
Requirements
- Academic degree in Biotechnology, Chemistry, Life Science, or related field
- Significant experience in GMP regulated pharmaceutical industry, preferably in Quality Unit
- Broad knowledge in CSV, Data Integrity, and related Guidelines (21 CFR Part 11, EU GMP Annex 11, GAMP5)
- Experience interacting with organizational interfaces and regulatory agencies (Swissmedic, FDA)
- Working knowledge of ERP (SAP), MES (Syncade), and DCS (DeltaV)
- Working knowledge of Recipe Testing & Verification (RTV)
- Excellent verbal, written, and interpersonal communication skills
- Fluency in English
- German language skills advantageous
Tasks
- Manage Quality and Compliance for computerized systems
- Validate Syncade and DeltaV recipe objects for cGMP activities
- Oversee CSV activities for new facilities, equipment, and utilities
- Represent Quality in CAPEX project organization for CSV
- Review and release CSV documents and SOPs
- Provide guidance and recommendations as a Subject Matter Expert
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degree
Languages
- English – Native
- German – Basic
Tools & Technologies
- CSV
- Data Integrity
- 21 CFR Part 11
- EU GMP Annex 11
- GAMP5
- SAP
- MES
- Syncade
- DCS
- DeltaV
- Recipe Testing & Verification (RTV)
Benefits
Corporate Discounts
- Lifestyle benefits
- Leisure benefits
Family Support
- Family benefits
Career Advancement
- Agile career
Informal Culture
- Dynamic work culture
Purpose-Driven Work
- Inclusive and ethical workplace
Other Benefits
- Tailored local 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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Not a perfect match?
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LOLonza
QA Manager CSV, Capital Projects(m/w/x)
Visp
Full-timeOn-siteExperienced
Nejo AI Summary
CSV QA management for Syncade and DeltaV recipe objects in pharmaceutical CAPEX projects. Broad knowledge of CSV, Data Integrity, and regulatory guidelines required. Agile career path, lifestyle and family benefits.
Requirements
- Academic degree in Biotechnology, Chemistry, Life Science, or related field
- Significant experience in GMP regulated pharmaceutical industry, preferably in Quality Unit
- Broad knowledge in CSV, Data Integrity, and related Guidelines (21 CFR Part 11, EU GMP Annex 11, GAMP5)
- Experience interacting with organizational interfaces and regulatory agencies (Swissmedic, FDA)
- Working knowledge of ERP (SAP), MES (Syncade), and DCS (DeltaV)
- Working knowledge of Recipe Testing & Verification (RTV)
- Excellent verbal, written, and interpersonal communication skills
- Fluency in English
- German language skills advantageous
Tasks
- Manage Quality and Compliance for computerized systems
- Validate Syncade and DeltaV recipe objects for cGMP activities
- Oversee CSV activities for new facilities, equipment, and utilities
- Represent Quality in CAPEX project organization for CSV
- Review and release CSV documents and SOPs
- Provide guidance and recommendations as a Subject Matter Expert
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degree
Languages
- English – Native
- German – Basic
Tools & Technologies
- CSV
- Data Integrity
- 21 CFR Part 11
- EU GMP Annex 11
- GAMP5
- SAP
- MES
- Syncade
- DCS
- DeltaV
- Recipe Testing & Verification (RTV)
Benefits
Corporate Discounts
- Lifestyle benefits
- Leisure benefits
Family Support
- Family benefits
Career Advancement
- Agile career
Informal Culture
- Dynamic work culture
Purpose-Driven Work
- Inclusive and ethical workplace
Other Benefits
- Tailored local 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.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
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.
Not a perfect match?
- Lonza
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