Quality Assurance Specialist
The consultants will work with the Quality department to get their batch releases and documentation back on track with the business’ schedule also tackling a backlog of deviations.
Key Areas of accountability/responsibility
- Reviews and approves cGMP documents associated to the product in compliance with local and corporate SOPs and applicable legislation.
- Approves investigations assuring that they are complete, accurate, technically justified with the required documented evidence including risk assessment.
- Review and approval of Process and Product Validation and Qualification Reports.
- Review and approval of Testing Validation and Qualification Reports.
- Perform the investigation of Product Complaints and Recalls.
- Evaluates and approves Changes associated with the product.
- Plan, perform and monitor in collaboration with the project manager QA activities within the project to ensure results are according the agreement and regulatory expectations.
Please apply now for more information!
The candidate must have the rights to work in the location stated in the job advert.
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