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Quality Assurance Expert Analytics, Drug Product Services(m/w/x)
Reviewing and approving analytical methods and validation protocols for biological drug products. Master's degree and 5-6 years of cGMP experience required. Ethical workplace, performance-based compensation programs.
Requirements
- Master's degree or higher in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field
- Minimum 5-6 years experience in Quality Assurance in pharmaceutical industries and cGMP
- Good working knowledge of EU and US GMP regulations
- Sound knowledge in testing of biological drug products
- Excellent communication and decision-making skills
- Ability to provide solutions for complex challenges
- Ability to work independently
- Team player
- Detailed oriented
- Precise
- Pro-active
- Well organized
- Excellent knowledge of written and spoken English
Tasks
- Establish and maintain Quality Management System
- Ensure staff qualification and GMP adherence
- Review and approve analytical methods
- Review and approve qualification protocols
- Review and approve validation protocols
- Review and approve transfer protocols
- Review and approve analytical reports
- Review and approve analytical SOPs
- Supervise GMP compliance activities
- Execute GMP compliance activities
- Approve deviations for Analytics/Quality Control
- Approve deviations for OOS investigations
- Act as first contact for compliance issues
- Approve specifications in LIMS
- Counsel groups on projects
- Counsel groups on GMP aspects
Work Experience
- 5 - 6 years
Education
- Master's degree
Languages
- English – Business Fluent
Benefits
Purpose-Driven Work
- Inclusive and ethical workplace
Bonuses & Incentives
- Compensation programs that recognize high performance
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Quality Assurance Expert Analytics, Drug Product Services(m/w/x)
Reviewing and approving analytical methods and validation protocols for biological drug products. Master's degree and 5-6 years of cGMP experience required. Ethical workplace, performance-based compensation programs.
Requirements
- Master's degree or higher in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field
- Minimum 5-6 years experience in Quality Assurance in pharmaceutical industries and cGMP
- Good working knowledge of EU and US GMP regulations
- Sound knowledge in testing of biological drug products
- Excellent communication and decision-making skills
- Ability to provide solutions for complex challenges
- Ability to work independently
- Team player
- Detailed oriented
- Precise
- Pro-active
- Well organized
- Excellent knowledge of written and spoken English
Tasks
- Establish and maintain Quality Management System
- Ensure staff qualification and GMP adherence
- Review and approve analytical methods
- Review and approve qualification protocols
- Review and approve validation protocols
- Review and approve transfer protocols
- Review and approve analytical reports
- Review and approve analytical SOPs
- Supervise GMP compliance activities
- Execute GMP compliance activities
- Approve deviations for Analytics/Quality Control
- Approve deviations for OOS investigations
- Act as first contact for compliance issues
- Approve specifications in LIMS
- Counsel groups on projects
- Counsel groups on GMP aspects
Work Experience
- 5 - 6 years
Education
- Master's degree
Languages
- English – Business Fluent
Benefits
Purpose-Driven Work
- Inclusive and ethical workplace
Bonuses & Incentives
- Compensation programs that recognize high performance
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?
- Roche
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Full-timeOn-siteExperiencedRheinfelden (Baden) - Lonza
Project Lead Phys-Chem QC(m/w/x)
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Principal Scientist-Analytical Project Leader(m/w/x)
Full-timeOn-siteSeniorBasel