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QA Expert, Manufacturing Release(m/w/x)
Batch release for aseptic drug products, including SOPs and change control. GMP compliance and deviation management experience required. Relocation assistance, agile career path.
Requirements
- BSc, MSc, or PhD in Natural Sciences or Pharmaceutical Sciences
- Experience in sterile drug product or substance manufacturing in GMP environment
- Experience in deviation and change management
- Work experience in QA is advantageous
- Hands-on personality, open approach to business partners, excellent influencing and negotiation skills
- Fluency in English
- German language skills are advantageous
Tasks
- Perform batch release for aseptic manufactured drug products
- Write, review, and approve procedures, SOPs, risk assessments, and gap assessments
- Ensure GMP compliance in electronic systems and paper-based documents
- Approve change requests, deviations, and CAPAs related to product and process
- Promote and enforce compliance with internal and external quality and safety guidelines
- Ensure required knowledge and skills, identify competency gaps, and develop solutions
- Lead development and evaluation of new tools, processes, and quality initiatives
- Be present at the manufacturing line to support manufacturing activities
- Support projects and maintain Sterile Production Stein line functions in GMP compliance
Work Experience
- approx. 1 - 4 years
Education
- Doctoral / PhD
Languages
- English – Fluent
- German – Basic
Benefits
Other Benefits
- Relocation assistance
Career Advancement
- Agile career
Informal Culture
- Dynamic work culture
Purpose-Driven Work
- Inclusive and ethical workplace
Bonuses & Incentives
- Compensation programs for high performance
Corporate Discounts
- Lifestyle benefits
- Leisure benefits
Family Support
- Family benefits
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QA Expert, Manufacturing Release(m/w/x)
Batch release for aseptic drug products, including SOPs and change control. GMP compliance and deviation management experience required. Relocation assistance, agile career path.
Requirements
- BSc, MSc, or PhD in Natural Sciences or Pharmaceutical Sciences
- Experience in sterile drug product or substance manufacturing in GMP environment
- Experience in deviation and change management
- Work experience in QA is advantageous
- Hands-on personality, open approach to business partners, excellent influencing and negotiation skills
- Fluency in English
- German language skills are advantageous
Tasks
- Perform batch release for aseptic manufactured drug products
- Write, review, and approve procedures, SOPs, risk assessments, and gap assessments
- Ensure GMP compliance in electronic systems and paper-based documents
- Approve change requests, deviations, and CAPAs related to product and process
- Promote and enforce compliance with internal and external quality and safety guidelines
- Ensure required knowledge and skills, identify competency gaps, and develop solutions
- Lead development and evaluation of new tools, processes, and quality initiatives
- Be present at the manufacturing line to support manufacturing activities
- Support projects and maintain Sterile Production Stein line functions in GMP compliance
Work Experience
- approx. 1 - 4 years
Education
- Doctoral / PhD
Languages
- English – Fluent
- German – Basic
Benefits
Other Benefits
- Relocation assistance
Career Advancement
- Agile career
Informal Culture
- Dynamic work culture
Purpose-Driven Work
- Inclusive and ethical workplace
Bonuses & Incentives
- Compensation programs for high performance
Corporate Discounts
- Lifestyle benefits
- Leisure benefits
Family Support
- Family benefits
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.
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