The role of Quality Assurance Specialist encompasses oversight of all validation activities ensuring compliance with current regulatory requirements and company standard operating procedures. Key responsibilities include qualification/validation of facilities, utilities, equipment, computerized systems, cleaning processes, manufacturing processes, storage areas, controlled temperature units, and shipping processes.
Key Responsibilities:
* Ensure quality oversight of qualification/validation activities
* Review and approve validation documentation and associated data
* Provide support in inspections and audits
* Provision of QA Validations expertise to maintain validation status
Requirements:
* Deep knowledge of GxP regulations and industry standards applicable to validation
* Strong planning, organisational, and time management skills
* Critical thinking skills
* Able to operate across functional boundaries
* Education background/ Experience Bachelor's degree 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