Quality assurance is crucial in ensuring compliance with regulatory requirements.
Job Description:
The Senior Quality Assurance Specialist role involves oversight of validation activities to ensure quality and safety.
Responsibilities:
* Ensure quality oversight of qualification/validation activities
* Review and approve validation documentation and associated data
* Provide QA oversight for events/deviations, investigations, and change evaluations
* Review SOPs relating to qualification/validation activities
* Support regulatory inspections and audits
* Maintain validation status of the facility
Requirements:
* Deep knowledge of GxP regulations applicable to biologics manufacturing
* Knowledge of trouble shooting and problem-solving skills
* Strong planning, organisational, and time management skills
* Critical thinking skills
* Education background/experience: B.Sc. or B.Eng in a scientific or engineering related discipline