Description
A Leading Biopharmaceutical manufacturing campus currently has a contract requirement for x2 experienced QA Validation Specialists. Working on their new Greenfield biotech manufacturing in Denmark as their QAV Specialists you will be required to review and approve validation documents and reports.Responsibilities to include:
* To review validation strategies and ensure adequate for FDA review.
* To review validation documentation according to current GMP practices.
* To ensure that all documentation is prepared, authorised and completed in a timely manner.
* To ensure that validations are performed to current regulatory and industry standards.
* To ensure compliance to the section and site`s procedures.
* To liaise with various departments involved in the qualification and validation work to ensure efficient performance of the related tasks.
* Ensure cGMP is applied in their area of work and comply with cGMP in all areas of the business.
* Provide quality oversight system validation and compliance.
To be successful for this Quality Assurance Validation Specialist we require the following:
* Education: Degree in either engineering or science
* Extensive experience within a biopharmaceutical manufacturing environment
* Profound working knowledge of completing QA review of validation strategies and protocols
* Experience from a QA perspective of reviewing the following validation documents: cleaning validation; equipment validation reports (equipment including freezers, tanks, skids)
This is an exciting opening to work in dynamic team in long term contract opportunity. Please apply now for more information.