Senior Quality Assurance
Location: Netherlands The Company
One of the global leaders in producing complex biological medicines and vaccines, contributing and improving millions of lives worldwide. They manufacture and market unique biopharmaceuticals and in doing so are building on their leading position in development of monoclonal antibodies. Their products help solve one of the most important medical needs of our time in immunology, cardiovascular and metabolic diseases, neuroscience and oncology.
Job Description
As Senior Quality Assurance you will be responsible for reviewing of batch and validation of documentation, completion of release packages and management of routine issues to ensure the highest level of quality and compliance of all products.
This position requires knowledge of the requirements for the production and release of biologics products in the EU and associated countries as well as in depth knowledge of deviation management processes.
Responsibilities
- Interact with Internal Quality Assurance Managers and External Manufactures to perform batch record review and complete release packages for global markets
- Ensure that all relevant QA related concerns at external manufacturing sites are raised to management
- Ensure that specific manufacturing operations at external sites are executed in a compliant manner
- Consult with account manager for resolution of major issues
Requirements
- Minimum of 5 years of experience working with pharmaceutical GMPs, specifically biopharmaceutical experience is preferred (QA and/or production)
- Minimum of 8 years of experience working in an FDA or similar regulated environment; Quality Assurance experience preferred
- Strong interpersonal and written/oral communication skills
- Fluent English is mandatory, other languages are a plus
Other Information
If you think this role is for you and you want to explore more of the possibilities, please contact Luka Babocajic and apply via the button below.
One of the global leaders in producing complex biological medicines and vaccines, contributing and improving millions of lives worldwide. They manufacture and market unique biopharmaceuticals and in doing so are building on their leading position in development of monoclonal antibodies. Their products help solve one of the most important medical needs of our time in immunology, cardiovascular and metabolic diseases, neuroscience and oncology.
Job Description
As Senior Quality Assurance you will be responsible for reviewing of batch and validation of documentation, completion of release packages and management of routine issues to ensure the highest level of quality and compliance of all products.
This position requires knowledge of the requirements for the production and release of biologics products in the EU and associated countries as well as in depth knowledge of deviation management processes.
Responsibilities
- Interact with Internal Quality Assurance Managers and External Manufactures to perform batch record review and complete release packages for global markets
- Ensure that all relevant QA related concerns at external manufacturing sites are raised to management
- Ensure that specific manufacturing operations at external sites are executed in a compliant manner
- Consult with account manager for resolution of major issues
Requirements
- Minimum of 5 years of experience working with pharmaceutical GMPs, specifically biopharmaceutical experience is preferred (QA and/or production)
- Minimum of 8 years of experience working in an FDA or similar regulated environment; Quality Assurance experience preferred
- Strong interpersonal and written/oral communication skills
- Fluent English is mandatory, other languages are a plus
Other Information
If you think this role is for you and you want to explore more of the possibilities, please contact Luka Babocajic and apply via the button below.
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