Quality Assurance Validation Specialist

Responsibilities   Act as Quality Assurance approver for qualification/validation lifecycle documents. Serve as a quality assurance resource for assessing validation requirements, non-conformance, impact assessments, root cause analysis and implementation of CAPA found during CQV activities. Provide Quality Assurance Validation support for Steam In Place (SIP) of buffer and media preparation systems, upstream (bioreactors) and downstream […]

Quality Assurance Specialist

Provide Quality oversight on the design and qualification activities as part of the design, construction, qualification and start-up of the new facility.   Responsibilities   Supporting the qualification and validation activities and agreeing best practices in line with applicable GMP Regulations. Quality SME for the execution and reporting phases of the qualification and validation activities […]

Quality Assurance Specialist

Responsibilities   Responsible for ensuring that the manufacturing processes for vaccines and biologics follow cGMP and associated regulatory requirements. Responsible for reviewing and approving documentation to support corporate compliance / regulatory expectations for manufacturing and supporting the site Quality Assurance function in ensuring that an effective internal and external auditing program is in place. Responsible […]