CH12 Lonza AG
Senior QA Specialist(m/w/x)
Full-timeOn-siteSenior
Visp
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Defining quality requirements for biopharmaceutical manufacturing processes and cGMP standards. Experience interacting with health authorities required. Relocation assistance provided.
Requirements
- Academic degree in Chemistry, Biotechnology, Life Science, or related field
- Solid experience in GMP regulated pharmaceutical industry, preferably QA role
- General knowledge of biopharmaceutical manufacturing processes and analytical methods
- Experience interacting with health authorities (Swissmedic, FDA etc.)
- Ability to oversee project execution to identify non-compliance
- Ability to prioritize and manage work to critical project timelines
- Structured, focused, and well-organized working attitude
- Open-minded for new ideas and suggestions
- Agile, highly motivated, and dynamic drive
- Strong team orientation
- Excellent verbal, written, and interpersonal communication skills
- Business fluent English
- Good German skills
Tasks
- Specify quality requirements for manufacturing processes and cGMP standards
- Participate in cross-functional project teams to ensure product safety and quality
- Own quality responsibilities for biopharmaceutical manufacturing processes
- Represent QA in project and tech transfer organizations for new biotech processes
- Review and release records including SOPs, batch records, material specifications, deviations, change requests, and testing protocols
- Assess product-related changes and their impact on regulatory filings
- Implement and approve change controls for customer requirements
- Investigate and document deviations and customer product complaints
- Identify and communicate emerging QA topics to the IBEX QA organization
- Develop new or existing Quality and Compliance strategies and standards
- Train and mentor junior employees in quality-related duties
- Support cGMP training programs to ensure staff competency
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Basic
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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Defining quality requirements for biopharmaceutical manufacturing processes and cGMP standards. Experience interacting with health authorities required. Relocation assistance provided.
Requirements
- Academic degree in Chemistry, Biotechnology, Life Science, or related field
- Solid experience in GMP regulated pharmaceutical industry, preferably QA role
- General knowledge of biopharmaceutical manufacturing processes and analytical methods
- Experience interacting with health authorities (Swissmedic, FDA etc.)
- Ability to oversee project execution to identify non-compliance
- Ability to prioritize and manage work to critical project timelines
- Structured, focused, and well-organized working attitude
- Open-minded for new ideas and suggestions
- Agile, highly motivated, and dynamic drive
- Strong team orientation
- Excellent verbal, written, and interpersonal communication skills
- Business fluent English
- Good German skills
Tasks
- Specify quality requirements for manufacturing processes and cGMP standards
- Participate in cross-functional project teams to ensure product safety and quality
- Own quality responsibilities for biopharmaceutical manufacturing processes
- Represent QA in project and tech transfer organizations for new biotech processes
- Review and release records including SOPs, batch records, material specifications, deviations, change requests, and testing protocols
- Assess product-related changes and their impact on regulatory filings
- Implement and approve change controls for customer requirements
- Investigate and document deviations and customer product complaints
- Identify and communicate emerging QA topics to the IBEX QA organization
- Develop new or existing Quality and Compliance strategies and standards
- Train and mentor junior employees in quality-related duties
- Support cGMP training programs to ensure staff competency
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Basic
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.
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?
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