Senior Quality Assurance Specialist Role
The role of Senior Quality Assurance Specialist encompasses the responsibility of overseeing all validation activities to ensure compliance with regulatory requirements and company SOPs.
This position involves validation/qualification activities for facilities, utilities, equipment, computerized systems, cleaning processes, storage areas, controlled temperature units (CTUs) and shipping.
Key Responsibilities:
* Ensure quality oversight of qualification/validation activities
* Review and approve validation documentation and associated data
* Provide QA oversight during events/deviations and change evaluations
* Review SOPs relating to qualification/validation activities
* Provide QA validations expertise to maintain validation status of the facility
* Maintain an understanding of cGMP regulations and guidance
Requirements and Qualifications:
To be successful in this role, you will require a B.Sc or B.Eng in a scientific or engineering-related discipline.
* Experience in a Quality Engineering/Quality Assurance/Quality Validations role for Biologics or related pharmaceutical/medical device manufacturing is necessary
* A thorough understanding of validation requirements and GxP regulations is essential
* Knowledge of troubleshooting and problem-solving skills is also required
* Formal root cause analysis methods and tools are beneficial