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Quality Assurance Specialist Qualification(m/w/x)
QA representation in multidisciplinary teams for life-saving vaccine development. 5 years GxP pharma/biotech experience, 3 years validation/qualification required. Hands-on risk assessments for equipment and facilities.
Requirements
- Master’s degree in Engineering, Biotechnology, or related field
- Minimum of 5 years relevant experience in GxP regulated pharmaceutical/biotechnology industry
- Minimum of 3 years validation and qualification experience
- Solid computer skills including MS Office
- Analytical thinking and problem-solving attitude
- Ability to work independently
- Fluency in German and English, both written and spoken
Tasks
- Act as the QA representative in multidisciplinary teams
- Provide guidance on quality assurance practices
- Ensure compliance with regulatory requirements
- Oversee and approve qualification and validation documentation
- Conduct risk assessments for equipment and facilities
- Support the implementation of qualification strategies for equipment and utilities
- Assist in the transition from project to commercial production phase
- Ensure compliance of quality systems with regulatory expectations
- Establish and improve quality procedures in your area of responsibility
- Continuously enhance allocated quality systems
- Support changes and corrections within your area
- Participate in audits and inspections related to your responsibilities
Work Experience
- 3 years
Education
- Master's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- MS Office
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Quality Assurance Specialist Qualification(m/w/x)
QA representation in multidisciplinary teams for life-saving vaccine development. 5 years GxP pharma/biotech experience, 3 years validation/qualification required. Hands-on risk assessments for equipment and facilities.
Requirements
- Master’s degree in Engineering, Biotechnology, or related field
- Minimum of 5 years relevant experience in GxP regulated pharmaceutical/biotechnology industry
- Minimum of 3 years validation and qualification experience
- Solid computer skills including MS Office
- Analytical thinking and problem-solving attitude
- Ability to work independently
- Fluency in German and English, both written and spoken
Tasks
- Act as the QA representative in multidisciplinary teams
- Provide guidance on quality assurance practices
- Ensure compliance with regulatory requirements
- Oversee and approve qualification and validation documentation
- Conduct risk assessments for equipment and facilities
- Support the implementation of qualification strategies for equipment and utilities
- Assist in the transition from project to commercial production phase
- Ensure compliance of quality systems with regulatory expectations
- Establish and improve quality procedures in your area of responsibility
- Continuously enhance allocated quality systems
- Support changes and corrections within your area
- Participate in audits and inspections related to your responsibilities
Work Experience
- 3 years
Education
- Master's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- MS Office
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Bavarian Nordic Berna GmbH
Industry
Pharmaceuticals
Description
The company is a global leader in developing life-saving vaccines with over 30 years of experience.
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