Specialist Quality Assurance Qualification & Validation (f/m/d)
Jobbeschreibung
Thörishaus, Bern, Schweiz
Bavarian Nordic Berna GmbH
18.05.2024
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Your responsibilities:
Responsible, as QA representative in multidisciplinary teams, to oversee and review/approve qualification/validation documents and risk assessments for the following topics:
Qualification of Equipment, Facilities, Utilities
Computer System Validation (CSV)
In this role the QA Specialist:
leads the implementation of the qualification/validation strategy
supports the transfer from project into commercial production phase
is the QA representative during qualification/validation work
ensures that the allocated quality-systems are compliant with regulatory expectations
establishes and continuously improves quality procedures within the area of responsibility
continuously improves the allocated quality systems
supports changes and corrections for the area of responsibility
participates in audits and inspection within the area of responsibility
What you bring to the table:
Master’s degree in Engineering, Biotechnology, or related field.
Minimum of 5 years relevant experience in a GxP regulated pharmaceutical/biotechnology industry.
Minimum of 3 years validation and qualification experience required
Solid computer skills including MS Office required.
Analytical thinking and problem-solving attitude
Multilingual – at least German and English, written and spoken
We provide an opportunity to be a part of an international company that boasts exceptional technology and a determined team. Join our dedicated and agile IT team if you share our enthusiasm and have a desire to create an impact. You can expect a vibrant and adaptable work environment that supports the growth of your personal and academic skills. Additionally, we offer an extensive benefits package and a competitive compensation package.
Caught your interest?
We look forward to receiving your application directly on our recruiting portal:
Responsible, as QA representative in multidisciplinary teams, to oversee and review/approve qualification/validation documents and risk assessments for the following topics:
Qualification of Equipment, Facilities, Utilities
Computer System Validation (CSV)
In this role the QA Specialist:
leads the implementation of the qualification/validation strategy
supports the transfer from project into commercial production phase
is the QA representative during qualification/validation work
ensures that the allocated quality-systems are compliant with regulatory expectations
establishes and continuously improves quality procedures within the area of responsibility
continuously improves the allocated quality systems
supports changes and corrections for the area of responsibility
participates in audits and inspection within the area of responsibility
What you bring to the table:
Master’s degree in Engineering, Biotechnology, or related field.
Minimum of 5 years relevant experience in a GxP regulated pharmaceutical/biotechnology industry.
Minimum of 3 years validation and qualification experience required
Solid computer skills including MS Office required.
Analytical thinking and problem-solving attitude
Multilingual – at least German and English, written and spoken
We provide an opportunity to be a part of an international company that boasts exceptional technology and a determined team. Join our dedicated and agile IT team if you share our enthusiasm and have a desire to create an impact. You can expect a vibrant and adaptable work environment that supports the growth of your personal and academic skills. Additionally, we offer an extensive benefits package and a competitive compensation package.
Caught your interest?
We look forward to receiving your application directly on our recruiting portal:
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Specialist Quality Assurance Qualification & Validation (F/M/D)
Bavarian Nordic Berna GmbH
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