Dein persönlicher KI-Karriere-Agent
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 3 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Deutsch – verhandlungssicher
- Englisch – verhandlungssicher
Tools & Technologien
- 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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 3 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Deutsch – verhandlungssicher
- Englisch – verhandlungssicher
Tools & Technologien
- MS Office
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
Bavarian Nordic Berna GmbH
Branche
Pharmaceuticals
Beschreibung
The company is a global leader in developing life-saving vaccines with over 30 years of experience.
Noch nicht perfekt?
- Bavarian Nordic Berna GmbH
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Scientific Expert Quality Assurance 100%(m/w/x)
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Specialist Quality Assurance 100% - Spätschicht(m/w/x)
Vollzeitnur vor OrtKeine AngabeBern - CSL Behring
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